Data / Medical devices / United States / Teleflex LLC (NADC)

Teleflex LLC (NADC): FDA-registered device maker in Olive Branch, MS, United States, 253 510(k) clearances

Name: Teleflex LLC (NADC) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Teleflex LLC (NADC) is registered with the FDA (registration 3010041511) in Olive Branch, MS, United States. It lists 463 device types. The FDA files 253 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Teleflex LLC (NADC)

FDA registration number: 3010041511
Address: 11245 N Distribution Cove, Olive Branch, MS, United States, 38654
Owner or operator: Teleflex (9062981)
Roles: Manufacturer, Repackager or relabeler
First device listed: August 3, 1992
Registered through: 2027
Brand names listed: (K792088), , GEN, 12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set, 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter, 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set, 3mm Xcel, 5mm Biozip, 5mm Biozip Hss and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Adaptor, Catheter	GCE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Adenotome	KBH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Airway, Oropharyngeal, Anesthesiology	CAE	1	Repackager or relabeler	accessdata.fda.gov
Anesthesia Conduction Kit	CAZ	2	Repackager or relabeler	accessdata.fda.gov
Apparatus, Autotransfusion	CAC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apparatus, Electrosurgical	HAM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, Nonpowered	GCY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Applicator, Ent	KCJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Attachment, Eyepiece, For Insertion Of Prescription Lens	FDZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Attachment, Teaching, For Endoscope	FEA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Awl	HWJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Basin, Emesis	FNY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bedpan	FOB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bender	HXW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	GCA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Biopsy Needle	FCG	2	Repackager or relabeler	accessdata.fda.gov
Biopsy Needle Kit	POZ	2	Repackager or relabeler	accessdata.fda.gov
Bistoury, Tracheal	KCC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Blade, Scalpel	GES	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Block, Cutting, Ent, Sterile	JXS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bottle, Hot/Cold Water	FPF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	FAT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bougie, Esophageal, Ent	KCD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bougie, Urological	FAX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Box, Battery, Rechargeable	FCO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Brace, Drill	HXY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Brush, Cleaning, Tracheal Tube	EPE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Burr, Corneal, Manual	HOF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Caliper, Ophthalmic	HOE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Camera, Still, Endoscopic	FXM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-Disposable	FBM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Ear	JYC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Injection	FGY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	MXY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Sinus	KAM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Carrier, Ligature	GEJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Carrier, Sponge, Endoscopic	FGS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Conduction, Anesthetic	BSO	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Embolectomy	DXE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Hemodialysis, Implanted	MSD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Hemodialysis, Non-Implanted	MPB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Multiple Lumen	GBP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Subclavian	LFJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Catheter, Ventricular, General & Plastic Surgery	GBS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chest Drainage Kit	PAD	2	Repackager or relabeler	accessdata.fda.gov
Chisel (Osteotome)	KDG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chisel, Bone, Surgical	EML	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chisel, Mastoid	JYD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chisel, Middle-Ear	JYE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chisel, Nasal	KAN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chisel, Osteotome, Surgical	EMM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp	HXD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Cannula	FKC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Circumcision	HFX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Eyelid, Ophthalmic	HOD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Muscle, Ophthalmic	HOB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Non-Electrical	FFN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Penile	FHA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Umbilical	HFW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Uterine	HGC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cleaners, Medical Devices	MDZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clip, Aneurysm	HCH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clip, Implantable	FZP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clip, Removable (Skin)	FZQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clip, Scalp	HBO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Clip, Vascular	DSS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Connector, Catheter	GCD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Contractor, Surgical	FZR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Corkscrew	HWI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Countersink	HWW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Crimper, Pin	HXQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Crimper, Wire, Ent, Sterile	JXT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Crusher, Spur, Colostomy	FHH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Adenoid	KBJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Ear	JYG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Ethmoid	KAO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Nasal	KAP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Ophthalmic	HNZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Salpingeal	KBK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Suction, Endometrial (And Accessories)	HHK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Curette, Uterine	HCY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cutter, Surgical	FZT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cutter, Wire	HXZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Cystotome	HNY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Depressor, Metal Tongue, Surgical	KBL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Depressor, Orbital	HNX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Cystometric, Hydraulic	FEN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Intravascular Catheter Securement	KMK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Locking, For Intestinal Clamp	FFR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Measuring, Lens Radius, Ophthalmic	HLF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Device, Occlusion, Umbilical	FOD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Catheter	GCC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Esophageal (Metal Olive) Gastro-Urology	EZM	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Esophageal, Ent	KCF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Rectal	FFP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Tracheal	KCG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Vaginal	HDX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dilator, Vessel, Surgical	DWP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Flexible	FGO	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dissector, Tonsil	KBM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dressing, Wound And Burn, Occlusive	MGP	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ear, Nose, And Throat Surgical Tray	OGR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)	HGI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrode, Pacemaker, Temporary	LDF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Elevator, Ent	KAD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Cholangiogram Kit	NWT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Esophagoscope (Flexible Or Rigid)	EOX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Excavator, Ear	JYH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Extractor	HWB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
File	HTP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
File, Bone, Surgical	EMI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
File, Surgical, General & Plastic Surgery	GEO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Bronchoscope (Rigid)	JEK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Ent	KAE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Obstetrical	HDA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Rongeur, Surgical	EMH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Surgical, Gynecological	HCZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Tube Introduction	BWB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Forceps, Wire Closure, Ent, Sterile	JXX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Fork	HXE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Fork, Tuning	GWX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gag, Mouth	KBN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gauge, Lens, Ophthalmic	HLN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gauge, Measuring	JYJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal	EFQ	U	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gouge, Nasal, Ent	KAQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler	accessdata.fda.gov
Graft, Vascular, Stainless Steel Tunneler	MZY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hammer, Surgical	FZY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Head, Surgical, Hammer	GFB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Headlamp, Operating, Ac-Powered	HPQ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Headlight, Fiberoptic Focusing	FCT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemostat	HRQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hemostat, Surgical	EMD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Holder, Ear Speculum	JYK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Holder, Speculum, Ent	KAG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hook, Bone	KIK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hook, Fibroid, Gynecological	HDE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hook, Microsurgical Ear	JYL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Hook, Tracheal	KCH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Illuminator, Fiberoptic, Surgical Field	HBI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Impactor	HWA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Implantable Transprostatic Tissue Retractor System	PEW	2	Repackager or relabeler	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Inserter, Myringotomy Tube	JYM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Cast Application/Removal, Manual	LGG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Clip Removal	HBQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Hand, Calculus Removal	ELA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, General Obstetric-Gynecologic	KOH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Measuring, Corneal Radius	HJB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Special Lens, For Endoscope	FEI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Introducer, Sphere	HNP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Irrigator, Sinus	KAR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Kit, Repair, Catheter, Hemodialysis	NFK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Amputation	GDN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Ear	JYO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Ent	KTG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Laryngeal	JZY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Myringotomy	JYP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Nasal	KAS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Surgical	EMF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Knife, Tonsil	KBQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lamp, Operating-Room	FQP	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lamp, Surgical	FTD	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscopic Accessories, Gynecologic	NWV	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscopy Kit	FDE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Nasopharyngoscope	EQN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light Source, Endoscope, Xenon Arc	GCT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Headband, Surgical	FSR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Surgical Headlight	EBA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Ceiling Mounted	FSY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Connector	FSX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Light, Surgical, Endoscopic	FSW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Locator, Magnetic	FTZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Loop, Wire	JYQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mallet	HXL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Marker, Cardiopulmonary Bypass (Vein Marker)	MAB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Marker, Ocular	HMR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Marker, Sclera	HMQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mediastinoscope, Surgical	EWY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical, Absorbable, Staple Line Reinforcement	OXC	2	Manufacturer	accessdata.fda.gov
Mirror, Ent	KAI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mirror, General & Plastic Surgery	FTX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mirror, Headband, Ophthalmic	HKF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mobilizer, Ent	KAJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Multi-Lumen Hemodialysis Catheterization Kit	PPO	2	Repackager or relabeler	accessdata.fda.gov
Needle, Aspiration And Injection, Reusable	GDM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Biopsy, Cardiovascular	DWO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Catheter	GCB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Cerclage, Gynecological	HDH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Conduction, Anesthetic (W/Wo Introducer)	BSP	2	Repackager or relabeler	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Suturing, Disposable	GAB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Needle, Tumor Localization	MIJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nipper, Malleus	JYR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Occluder, Catheter Tip	DQT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Operating Room Accessories Table Tray	FWZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Osteotome	HWM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Osteotome, Manual	GFI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Otoscope	ERA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Paracentesis Tray	PYC	1	Repackager or relabeler	accessdata.fda.gov
Passer	HWQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	DXZ	2	Repackager or relabeler	accessdata.fda.gov
Pelvimeter, External	HER	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pen, Marking, Surgical	HRP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Percutaneous Atrial Catheter Kit	OFK	2	Repackager or relabeler	accessdata.fda.gov
Perforator, Antrum	KAT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pick, Microsurgical Ear	JYT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pinwheel	GWY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pliers, Surgical	HTC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Probe	HXB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Probe And Director, Gastro-Urology	FGM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Probe, Ent	KAK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Probe, Lachrymal	HNL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Probe, Rectal, Non-Powered	EXX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Probe, Trabeculotomy	HNK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Prosthesis, Elbow, Constrained, Cemented	JDC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Protector, Dental	BRW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Protector, Skin Pressure	FMP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Pump, Infusion, Elastomeric	MEB	2	Repackager or relabeler	accessdata.fda.gov
Punch, Adenoid	KBS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Antrum	KAW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Biopsy, Surgical	EME	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Corneo-Scleral	HNJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Ent	KTF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Ethmoid	KAX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Nasal	KAY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Surgical	LRY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Punch, Tonsil	KBT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rack, Clip	HBR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rasp, Ear	JYY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rasp, Frontal-Sinus	KAZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rasp, Nasal	KBA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retention Device, Suture	KGS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Ent	KAL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Non-Self-Retaining	FGN	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Retractor, Vaginal	HDL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ring Cutter	FNS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ring, Laparotomy	FHI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Ring, Ophthalmic (Flieringa)	HNH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rod, Measuring Ear	JYZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rongeur	HTX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rongeur, Lachrymal Sac	HNG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rongeur, Manual	HAE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rongeur, Mastoid	JZA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Rongeur, Nasal	KBB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Saw	HSO	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Saw, Manual And Accessories	GDR	1	Repackager or relabeler	accessdata.fda.gov
Saw, Nasal	KBC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Ear	JZB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Episiotomy	HDK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Nasal	KBD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Umbilical	HDJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scissors, Wire Cutting, Ent, Sterile	JYA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scoop	FHL	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sizer, Heart-Valve, Prosthesis	DTI	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Snare, Ear	JZD	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Snare, Enucleating	HNE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Snare, Nasal	KBE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Snare, Tonsil	KBZ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sound, Urethral, Metal Or Plastic	FBX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sound, Uterine	HHM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Speculum, Ent	EPY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Speculum, Illuminated	FXF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Speculum, Non-Illuminated	FXE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Speculum, Rectal	FFQ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Metal, Fiberoptic	HDG	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sponge, Ophthalmic	HOZ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spoon, Ear	JZE	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Spud, Ophthalmic	HNA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stabilizer, Heart	MWS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Staple, Fixation, Bone	JDR	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Staple, Implantable	GDW	2	Manufacturer	accessdata.fda.gov
Stapler, Skin	QQS	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stopcock, I.V. Set	FMG	2	Repackager or relabeler	accessdata.fda.gov
Stripper, Artery, Intraluminal	DWX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov

63 more device types in the FDA listing

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 253.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 3, 2025	K251054	Hem-o-lok PurplePlus Large Polymer Ligating Clips	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
January 12, 2024	K232970	Hem-o-lok® Ligating Clips	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
October 6, 2023	K231603	Standard Staple-Line Reinforcement (SSLR23)	OXC	Substantially Equivalent	Standard Bariatrics, Inc.	accessdata.fda.gov
September 22, 2023	K232558	UroLift 2 ATC Advanced Tissue Control System	PEW	Substantially Equivalent	Neotract, Inc.	accessdata.fda.gov
April 28, 2023	K230480	Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
February 13, 2023	K222341	Arrow 0.2 Micron Flat Filter, GVS	CAZ	Substantially Equivalent	Arrow International, LLC	accessdata.fda.gov
October 31, 2022	K222085	Standard Tapered Bougie, 38 Fr.	KNT	Substantially Equivalent	Standard Bariatrics, Inc.	accessdata.fda.gov
April 28, 2021	K210278	Titan SGS	GDW	Substantially Equivalent	Standard Bariatrics	accessdata.fda.gov
July 31, 2020	K201837	UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge	PEW	Substantially Equivalent	Neotract, Inc.	accessdata.fda.gov
June 5, 2020	K200441	UroLift Advanced Tissue Control (ATC) System	PEW	Substantially Equivalent	Neotract, Inc.	accessdata.fda.gov
April 14, 2020	K192781	UroLift System Procedure Kit Sterilization Tray	KCT	Substantially Equivalent	Neotract, Inc.	accessdata.fda.gov
April 9, 2020	K200517	Standard Trocar	GCJ	Substantially Equivalent	Standard Bariatrics	accessdata.fda.gov
March 30, 2020	K192490	Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch	GAT	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
March 19, 2020	K193530	Deklene MAXX	GAW	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
December 20, 2019	K193269	UroLift System (UL400)	PEW	Substantially Equivalent	Neotract, Inc.	accessdata.fda.gov
October 12, 2018	K181852	Percuvance Percutaneous Surgical System	GEI	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
June 23, 2017	K171146	Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.	DQY	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Telelflex Inc.)	accessdata.fda.gov
March 17, 2017	K162522	UltraCath Continuous Nerve block Catheter	BSO	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
December 22, 2016	K160925	VPS Rhythm Device with TipTracker Technology	LJS	Substantially Equivalent	Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)	accessdata.fda.gov
November 23, 2016	K162396	SILK Surgical Suture	GAP	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
August 12, 2016	K153089	'cottony' II TAPE, PLEDGETS	GAT	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
June 21, 2016	K153652	ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set	CAZ	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
June 16, 2016	K153076	silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL	GAT	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
February 26, 2016	K152082	Vesocclude Polymer Ligating Clip	FZP	Substantially Equivalent	Vesocclude Medical, LLC	accessdata.fda.gov
April 2, 2015	K150438	Force Fiber OrthoTape suture	GAT	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
January 21, 2015	K143299	Percuvance(R) Percutaneous Surgical System	GCJ	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
December 19, 2014	K142777	Weck Hem-o-lok Auto Endo5 Ligating Clip Applier	FZP	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
December 17, 2014	K142377	The OnControl Bone Marrow Biopsy System by Vidacare	KNW	Substantially Equivalent	Vidacare, LLC	accessdata.fda.gov
October 23, 2014	K140205	PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM	CAC	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
October 21, 2014	K140197	PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM	CAC	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
July 7, 2014	K141051	VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE REPLACEMENT HU	MSD	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
June 16, 2014	K133439	PILLING ESOPHAGEAL BOUGIES	FAT	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
May 30, 2014	K130304	LMA FAMILY OF AIRWAYS	CAE	Substantially Equivalent	The Laryngeal Mask Co., Ltd.	accessdata.fda.gov
December 3, 2013	K133202	HEM-O-LOK LIGATING CLIP	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
November 27, 2013	K132658	HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
October 8, 2013	K132362	WECK EFX ENDO FASCIAL CLOSURE SYSTEM	OCW	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
September 26, 2013	K132133	CG+ ARROW JACC POWERED BY ARROW VPS STYLET	OBJ	Substantially Equivalent	Arrow International (Subsidiary of Teleflex Inc.)	accessdata.fda.gov
May 10, 2013	K130192	NEXTSTEP RETROGRADE	MSD	Unknown	Arrow International, Inc.	accessdata.fda.gov
April 26, 2013	K130876	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	LJS	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
February 12, 2013	K130043	PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM	CAC	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
January 18, 2013	K123813	VASCULAR POSITIONING SYSTEM (VPS) G4 CONSOLE	OBJ	Substantially Equivalent	Vasonova, Inc.	accessdata.fda.gov
January 4, 2013	K122854	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	DYB	Substantially Equivalent	Arrow International (Subsidiary of Teleflex Inc.)	accessdata.fda.gov
January 3, 2013	K123759	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	LJS	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Teleflex	accessdata.fda.gov
December 10, 2012	K120953	PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM	CAC	Substantially Equivalent	Tlelflex Medical, Inc.	accessdata.fda.gov
October 11, 2012	K121796	WECK REUSABLE OBTURATOR	GCJ	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
September 20, 2012	K122545	CG+ ARROW PICC POWERED BY ARROW VPS STYLET	LJS	Substantially Equivalent	Arrow International (Subsidiary of Teleflex Inc.)	accessdata.fda.gov
September 7, 2012	K121941	ARROW PICC POWERED BY ARROW VPS STYLET	LJS	Substantially Equivalent	Arrow International (Subsidiary of Teleflex Inc.)	accessdata.fda.gov
August 28, 2012	K122027	ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER	CAZ	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
June 21, 2012	K113277	ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS	LJS	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
June 20, 2012	K121403	CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET	CAZ	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
June 3, 2012	K113597	MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES	GEI	Substantially Equivalent	Minilap Technologies	accessdata.fda.gov
May 25, 2012	K121380	WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT	GCJ	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
May 16, 2012	K103658	FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER	CAZ	Substantially Equivalent	Teleflex, Inc.	accessdata.fda.gov
May 10, 2012	K112896	ARRW EVOLUTION	LJS	Substantially Equivalent	Arrow International (Subsidiary of Teleflex Inc.)	accessdata.fda.gov
November 18, 2011	K112554	TRANSRADIAL ARTERY ACCESS DEVICES	DYB	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
October 4, 2011	K112456	ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT	GCJ	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
August 17, 2011	K111900	NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER	MSD	Unknown	Teleflexmedical, Inc.	accessdata.fda.gov
June 30, 2011	K111117	CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...	MSD	Unknown	Teleflexmedical, Inc.	accessdata.fda.gov
February 18, 2011	K103260	VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE	OBJ	Substantially Equivalent	Vasonova, Inc.	accessdata.fda.gov
February 18, 2011	K103255	VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET	OBJ	Substantially Equivalent	Vasonova, Inc.	accessdata.fda.gov
February 1, 2011	K102238	ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER	MSD	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
December 30, 2010	K103412	AXIOM FASCIAL CLOSURE SYSTEM	OCW	Substantially Equivalent	Axiom Technology Partners, LLC	accessdata.fda.gov
November 18, 2010	K102146	BAHADIR STERILIZATION TRAYS	KCT	Substantially Equivalent	Bahadir USA Corp.	accessdata.fda.gov
August 27, 2010	K100635	ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504	LJS	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
March 10, 2010	K100506	FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK	GAT	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
December 18, 2009	K093050	ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520	DQY	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
December 3, 2009	K092840	INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL	HCZ	Substantially Equivalent	Instrumed International, Inc.	accessdata.fda.gov
November 20, 2009	K083754	MINI LAP ELECTROCAUTERY INSTRUMENTS	GEI	Substantially Equivalent	Mini Lap Technologies, Inc.	accessdata.fda.gov
October 26, 2009	K092544	INSTRUMED VASCULAR CLAMPS	DXC	Substantially Equivalent	Instrumed International, Inc.	accessdata.fda.gov
September 23, 2009	K091060	VESOCCLUDE LIGATING CLIP	FZP	Substantially Equivalent	Vesocclude Medical, LLC	accessdata.fda.gov
September 15, 2009	K092533	FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES	GAT	Substantially Equivalent	Beere Precision Medical Instruments, Kmedic, Telef	accessdata.fda.gov
April 30, 2009	K090300	MODIFICATION TO AUTOFUSER	MEB	Substantially Equivalent	Ace Medical Us, LLC	accessdata.fda.gov
September 10, 2008	K082156	ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213	GCJ	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
August 8, 2008	K081651	INSTRUMED RONGEUR	HAE	Substantially Equivalent	Instrumed International, Inc.	accessdata.fda.gov
June 27, 2008	K080604	PRESSURE INJFECTABLE PICC	LJS	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
June 9, 2008	K080684	WG-SURGICAL SUTURES WITH NEEDLE	GAP	Substantially Equivalent	Foosin Medical Supplies, Inc.	accessdata.fda.gov
January 15, 2008	K073451	PRESSURE INJECTABLE PICC	LJS	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
October 10, 2007	K071491	ARROW INTERNATIONAL, INC., SURGICAL DRAPES	KKX	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
September 26, 2007	K071998	ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT	FMI	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
August 30, 2007	K071538	ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER	FOZ	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
August 2, 2007	K071771	INSTRUMED RETRACTORS	GZT	Substantially Equivalent	Instrumed International, Inc.	accessdata.fda.gov
July 17, 2007	K071111	NON-ABSORBABLE SILK SUTURE	GAP	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
July 2, 2007	K070903	MYLAB40	ITX	Substantially Equivalent	Esaote Europe B.V.	accessdata.fda.gov
May 25, 2007	K070561	KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES	HTY	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
April 5, 2007	K070686	MINI LAP INSTRUMENTS	OCW	Substantially Equivalent	Mini Lap Technologies, Inc.	accessdata.fda.gov
April 2, 2007	K070673	FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE	GAT	Substantially Equivalent	Teleflexmedical, Inc.	accessdata.fda.gov
February 9, 2007	K063778	FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE	GAT	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
November 2, 2006	K062914	HEM-O-LOK LIGATION CLIP	FZP	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
August 24, 2006	K061289	ARROW PRESSURE INJECTABLE PICC	LJS	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
July 19, 2006	K060233	TROKAMED GMBH ENDOSCOPES AND ACCESSORIES	GCJ	Substantially Equivalent	Trokamed GmbH	accessdata.fda.gov
May 17, 2006	K060801	DEKNA-LOK MODEL BP1000V2L	GAM	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
May 5, 2006	K060519	INTRODUCER ASSEMBLY WITH ROTATOR LOCK	DYB	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
November 19, 2004	K042966	DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H	MAI	Substantially Equivalent	Linvatec Biomaterials, Ltd.	accessdata.fda.gov
September 28, 2004	K042141	POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE	GAM	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov
August 27, 2004	K042126	PICC	LJS	Unknown	Arrow Intl., Inc.	accessdata.fda.gov
July 12, 2004	K041153	SHARPSAWAY II LOCKING DISPOSABLE CUP	FMI	Substantially Equivalent	Arrow Intl., Inc.	accessdata.fda.gov
June 14, 2004	K041305	STRYKER BIOZIP SUTURE ANCHOR SYSTEM	MAI	Substantially Equivalent	Stryker Endoscopy	accessdata.fda.gov
May 14, 2004	K040666	STEP-TIP CHRONIC HEMODIALYSIS CATHETER	MSD	Substantially Equivalent	Arrow International, Inc.	accessdata.fda.gov
April 16, 2004	K040855	INSTRUMED LAPAROSCOPE AND ACCESSORIES	GEI	Substantially Equivalent	Instrumed International, Inc.	accessdata.fda.gov
March 15, 2004	K040472	FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE	GAT	Substantially Equivalent	Teleflex Medical	accessdata.fda.gov

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Updated July 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.