Data / Medical devices / United States / Sklar Corporation - Warehouse

Sklar Corporation - Warehouse: FDA-registered device maker in Salisbury, MD, United States, 33 510(k) clearances

Name: Sklar Corporation - Warehouse FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sklar Corporation - Warehouse is registered with the FDA (registration 3015895045) in Salisbury, MD, United States. It lists 225 device types. The FDA files 33 510(k) clearances under its listings, the newest dated November 8, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015895045
Address: 2015 Industrial Parkway, Salisbury, MD, United States, 21801
Owner or operator: Sklar Corporation (10023634)
Roles: Repackager or relabeler
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: Adenoid Curette, Amputation Knife, Applier, Arthroscopic Accessories, Articulators, Awl, Band Setter, Biopsy Forceps and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Repackager or relabeler	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Absorbent Tipped, Sterile	KXG	1	Repackager or relabeler	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Repackager or relabeler	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Repackager or relabeler	accessdata.fda.gov
Articulators	EJP	1	Repackager or relabeler	accessdata.fda.gov
Awl	HWJ	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Elastic	FQM	1	Repackager or relabeler	accessdata.fda.gov
Basin, Emesis	FNY	1	Repackager or relabeler	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Repackager or relabeler	accessdata.fda.gov
Blade, Scalpel	GES	1	Repackager or relabeler	accessdata.fda.gov
Blood Pressure Cuff	DXQ	2	Repackager or relabeler	accessdata.fda.gov
Bougie, Eustachian	KBI	1	Repackager or relabeler	accessdata.fda.gov
Bougie, Urological	FAX	1	Repackager or relabeler	accessdata.fda.gov
Brush, Cleaning, Tracheal Tube	EPE	1	Repackager or relabeler	accessdata.fda.gov
Brush, Scrub, Operating-Room	GEC	1	Repackager or relabeler	accessdata.fda.gov
Burnisher, Operative	EKJ	1	Repackager or relabeler	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Repackager or relabeler	accessdata.fda.gov
Caliper	KTZ	1	Repackager or relabeler	accessdata.fda.gov
Caliper, Ophthalmic	HOE	1	Repackager or relabeler	accessdata.fda.gov
Cannula And Trocar, Suprapubic, Non-Disposable	FBM	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Ear	JYC	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Manipulator/Injector, Uterine	LKF	2	Repackager or relabeler	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Repackager or relabeler	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Repackager or relabeler	accessdata.fda.gov
Carrier, Amalgam, Operative	EKI	1	Repackager or relabeler	accessdata.fda.gov
Carver, Dental Amalgam, Operative	EKH	1	Repackager or relabeler	accessdata.fda.gov
Carver, Wax, Dental	EIK	1	Repackager or relabeler	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Urological	KOD	2	Repackager or relabeler	accessdata.fda.gov
Chisel, Bone, Surgical	EML	1	Repackager or relabeler	accessdata.fda.gov
Chisel, Osteotome, Surgical	EMM	1	Repackager or relabeler	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Circumcision	HFX	2	Repackager or relabeler	accessdata.fda.gov
Clamp, Penile	FHA	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Rubber Dam	EEF	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Repackager or relabeler	accessdata.fda.gov
Clamp, Uterine	HGC	1	Repackager or relabeler	accessdata.fda.gov
Clip, Hemostatic	MCH	2	Repackager or relabeler	accessdata.fda.gov
Clip, Implantable	FZP	2	Repackager or relabeler	accessdata.fda.gov
Clip, Removable (Skin)	FZQ	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Repackager or relabeler	accessdata.fda.gov
Curette	HTF	1	Repackager or relabeler	accessdata.fda.gov
Curette, Adenoid	KBJ	1	Repackager or relabeler	accessdata.fda.gov
Curette, Ear	JYG	1	Repackager or relabeler	accessdata.fda.gov
Curette, Nasal	KAP	1	Repackager or relabeler	accessdata.fda.gov
Curette, Operative	EKE	1	Repackager or relabeler	accessdata.fda.gov
Curette, Ophthalmic	HNZ	1	Repackager or relabeler	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Repackager or relabeler	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Repackager or relabeler	accessdata.fda.gov
Curette, Uterine	HCY	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Surgical	FZT	1	Repackager or relabeler	accessdata.fda.gov
Cutter, Wire	HXZ	1	Repackager or relabeler	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Repackager or relabeler	accessdata.fda.gov
Depressor, Metal Tongue, Surgical	KBL	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Catheter	GCC	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Tracheal	KCG	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Urethral	KOE	2	Repackager or relabeler	accessdata.fda.gov
Dilator, Vaginal	HDX	2	Repackager or relabeler	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Repackager or relabeler	accessdata.fda.gov
Dispenser, Liquid Medication	KYX	1	Repackager or relabeler	accessdata.fda.gov
Dissector, Tonsil	KBM	1	Repackager or relabeler	accessdata.fda.gov
Electrode, Electrosurgical, Active, Urological	FAS	2	Repackager or relabeler	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Elevator	HTE	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Ent	KAD	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Repackager or relabeler	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Repackager or relabeler	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Repackager or relabeler	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Repackager or relabeler	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Repackager or relabeler	accessdata.fda.gov
Explorer, Operative	EKB	1	Repackager or relabeler	accessdata.fda.gov
File, Bone, Surgical	EMI	1	Repackager or relabeler	accessdata.fda.gov
File, Periodontic	EMR	1	Repackager or relabeler	accessdata.fda.gov
File, Surgical, General & Plastic Surgery	GEO	1	Repackager or relabeler	accessdata.fda.gov
Forceps	HTD	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Ent	KAE	1	Repackager or relabeler	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Obstetrical	HDA	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Repackager or relabeler	accessdata.fda.gov
Forceps, Surgical, Gynecological	HCZ	2	Repackager or relabeler	accessdata.fda.gov
Forceps, Tooth Extractor, Surgical	EMG	1	Repackager or relabeler	accessdata.fda.gov
Gag, Mouth	KBN	1	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
General Surgery Tray	LRO	2	Repackager or relabeler	accessdata.fda.gov
Gouge, Surgical, General & Plastic Surgery	GDH	1	Repackager or relabeler	accessdata.fda.gov
Gown, Surgical	FYA	2	Repackager or relabeler	accessdata.fda.gov
Guard, Instrument	LXZ	1	Repackager or relabeler	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Repackager or relabeler	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Repackager or relabeler	accessdata.fda.gov
Hammer, Surgical	FZY	1	Repackager or relabeler	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Repackager or relabeler	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Repackager or relabeler	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Repackager or relabeler	accessdata.fda.gov
Hook, Bone	KIK	1	Repackager or relabeler	accessdata.fda.gov
Hook, Microsurgical Ear	JYL	1	Repackager or relabeler	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Repackager or relabeler	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Repackager or relabeler	accessdata.fda.gov
Hook, Tonsil Suturing	KBP	1	Repackager or relabeler	accessdata.fda.gov
Hook, Tracheal	KCH	1	Repackager or relabeler	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Cast Application/Removal, Manual	LGG	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Filling, Plastic, Dental	EIY	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Repackager or relabeler	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Knife, Amputation	GDN	1	Repackager or relabeler	accessdata.fda.gov
Knife, Ear	JYO	1	Repackager or relabeler	accessdata.fda.gov
Knife, Nasal	KAS	1	Repackager or relabeler	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Repackager or relabeler	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Repackager or relabeler	accessdata.fda.gov
Knife, Surgical	EMF	1	Repackager or relabeler	accessdata.fda.gov
Label Or Tag, Sterile	LYV	1	Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Laparoscopy Kit	FDE	2	Repackager or relabeler	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Repackager or relabeler	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Repackager or relabeler	accessdata.fda.gov
Light Source, Endoscope, Xenon Arc	GCT	2	Repackager or relabeler	accessdata.fda.gov
Loupe, Diagnostic/Surgical	FSP	1	Repackager or relabeler	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Repackager or relabeler	accessdata.fda.gov
Marker, Skin	FZZ	1	Repackager or relabeler	accessdata.fda.gov
Mirror, Headband, Ophthalmic	HKF	1	Repackager or relabeler	accessdata.fda.gov
Mirror, Mouth	EAX	1	Repackager or relabeler	accessdata.fda.gov
Needle, Suturing, Reusable	GDL	1	Repackager or relabeler	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Repackager or relabeler	accessdata.fda.gov
Osteotome	HWM	1	Repackager or relabeler	accessdata.fda.gov
Otoscope	ERA	1	Repackager or relabeler	accessdata.fda.gov
Pessary, Vaginal	HHW	2	Repackager or relabeler	accessdata.fda.gov
Pick, Microsurgical Ear	JYT	1	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Smooth	HTY	2	Repackager or relabeler	accessdata.fda.gov
Pin, Fixation, Threaded	JDW	2	Repackager or relabeler	accessdata.fda.gov
Plastic Surgery And Accessories Kit	FTN	1	Repackager or relabeler	accessdata.fda.gov
Plier, Crimp	FJY	1	Repackager or relabeler	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Repackager or relabeler	accessdata.fda.gov
Pliers, Operative	EJY	1	Repackager or relabeler	accessdata.fda.gov
Pliers, Surgical	HTC	1	Repackager or relabeler	accessdata.fda.gov
Probe	HXB	1	Repackager or relabeler	accessdata.fda.gov
Probe And Director, Gastro-Urology	FGM	1	Repackager or relabeler	accessdata.fda.gov
Probe, Lachrymal	HNL	1	Repackager or relabeler	accessdata.fda.gov
Probe, Periodontic	EIX	1	Repackager or relabeler	accessdata.fda.gov
Punch, Biopsy, Surgical	EME	1	Repackager or relabeler	accessdata.fda.gov
Punch, Ent	KTF	1	Repackager or relabeler	accessdata.fda.gov
Punch, Skull	GXJ	1	Repackager or relabeler	accessdata.fda.gov
Punch, Surgical	LRY	1	Repackager or relabeler	accessdata.fda.gov
Rasp	HTR	1	Repackager or relabeler	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Repackager or relabeler	accessdata.fda.gov
Razor, Surgical	LWK	1	Repackager or relabeler	accessdata.fda.gov
Remover, Crown	EIS	1	Repackager or relabeler	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Repackager or relabeler	accessdata.fda.gov
Resectoscope	FJL	2	Repackager or relabeler	accessdata.fda.gov
Resectoscope, Working Element	FDC	2	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Repackager or relabeler	accessdata.fda.gov
Retractor	GAD	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Repackager or relabeler	accessdata.fda.gov
Retractor, Vaginal	HDL	1	Repackager or relabeler	accessdata.fda.gov
Ring Cutter	FNS	1	Repackager or relabeler	accessdata.fda.gov
Rongeur	HTX	1	Repackager or relabeler	accessdata.fda.gov
Sampler, Amniotic Fluid (Amniocentesis Tray)	HIO	1	Repackager or relabeler	accessdata.fda.gov
Saw	HSO	1	Repackager or relabeler	accessdata.fda.gov
Saw, Manual And Accessories	GDR	1	Repackager or relabeler	accessdata.fda.gov
Saw, Nasal	KBC	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Repackager or relabeler	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Repackager or relabeler	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Nasal	KBD	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Repackager or relabeler	accessdata.fda.gov
Scissors, Wire Cutting, Ent, Sterile	JYA	1	Repackager or relabeler	accessdata.fda.gov
Scoop	FHL	1	Repackager or relabeler	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Repackager or relabeler	accessdata.fda.gov
Screwdriver	HXX	1	Repackager or relabeler	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Repackager or relabeler	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Sound, Urethral, Metal Or Plastic	FBX	1	Repackager or relabeler	accessdata.fda.gov
Sound, Uterine	HHM	1	Repackager or relabeler	accessdata.fda.gov
Spatula, Cervical, Cytological	HHT	2	Repackager or relabeler	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Repackager or relabeler	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Repackager or relabeler	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Ent	EPY	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Rectal	FFQ	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Repackager or relabeler	accessdata.fda.gov
Speculum, Vaginal, Nonmetal	HIB	2	Repackager or relabeler	accessdata.fda.gov
Spoon, Ophthalmic	HNB	1	Repackager or relabeler	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Repackager or relabeler	accessdata.fda.gov
Stethoscope, Fetal	HGN	1	Repackager or relabeler	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Repackager or relabeler	accessdata.fda.gov
Stripper, Vein, Reusable	GAI	1	Repackager or relabeler	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Repackager or relabeler	accessdata.fda.gov
Syringe, Ent	KCP	1	Repackager or relabeler	accessdata.fda.gov
Tamp	HXG	1	Repackager or relabeler	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Repackager or relabeler	accessdata.fda.gov
Tonometer, Manual	HKY	2	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Tray, Impression, Preformed	EHY	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Repackager or relabeler	accessdata.fda.gov
Trephine, Manual, Ophthalmic	HRH	1	Repackager or relabeler	accessdata.fda.gov
Trocar	DRC	2	Repackager or relabeler	accessdata.fda.gov
Trocar, Ent	KTE	1	Repackager or relabeler	accessdata.fda.gov
Tube, Tonsil Suction	KCB	1	Repackager or relabeler	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Repackager or relabeler	accessdata.fda.gov
Twister, Wire	HXS	1	Repackager or relabeler	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Repackager or relabeler	accessdata.fda.gov
Urethroscope	FGC	2	Repackager or relabeler	accessdata.fda.gov
Urethrotome	EZO	2	Repackager or relabeler	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Repackager or relabeler	accessdata.fda.gov

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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 8, 2011	K111930	ACKERMANN EUROPCLIP	FZP	Substantially Equivalent	Ackermann Instrumente GmbH	accessdata.fda.gov
July 22, 2010	K092981	PANPAC VAGINAL PESSARY	HHW	Substantially Equivalent	Panpac Medical Corporation	accessdata.fda.gov
April 9, 2010	K091720	SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM	KCT	Substantially Equivalent	Sklar Corp.	accessdata.fda.gov
January 8, 2010	K092827	DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX	HDA	Substantially Equivalent	Dimeda Instrumente GmbH	accessdata.fda.gov
July 15, 2009	K083912	TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS	HWC	Substantially Equivalent	Treu-Instrumente GmbH	accessdata.fda.gov
April 24, 2009	K082479	SKLAR SURGICAL GOWN	FYA	Substantially Equivalent	Sklar Corp.	accessdata.fda.gov
August 15, 2008	K080189	TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX	DXQ	Substantially Equivalent	Trimline Medical Products Corp.	accessdata.fda.gov
October 18, 2004	K042608	TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110	GEI	Substantially Equivalent	Tecno Instruments (Pvt.) , Ltd.	accessdata.fda.gov
January 22, 2004	K033403	T.S. MEDICAL CIRCUMCISION CLAMP	HFX	Substantially Equivalent	T.S. Medical	accessdata.fda.gov
December 20, 2001	K012660	GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES	FET	Substantially Equivalent	Gimmi GmbH	accessdata.fda.gov
January 29, 2001	K003380	BIOTEQUE VAGINAL DILATOR	HDX	Substantially Equivalent	Bioteque America, Inc.	accessdata.fda.gov
October 19, 2000	K002257	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	GEI	Substantially Equivalent	Tecno Instruments (Pvt.) , Ltd.	accessdata.fda.gov
May 19, 2000	K001119	ROVERS ENDOCERVEX-BRUSH	HHT	Substantially Equivalent	Rovers Medical Devices B.V.	accessdata.fda.gov
July 17, 1998	K981891	AMBU TUBECHECK	BTR	Substantially Equivalent	Ambu, Inc.	accessdata.fda.gov
April 21, 1998	K974382	ACKERMANN SURGICAL INSTRUMENTS	GCJ	Substantially Equivalent	Ackermann Instrumente GmbH	accessdata.fda.gov
August 14, 1997	K964176	TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPS	GEI	Substantially Equivalent	Tecno Instruments (Usa), Inc.	accessdata.fda.gov
June 9, 1997	K971062	OPPORTUNITY INC. GENERAL PURPOSE TRAY	LRO	Substantially Equivalent for Some Indications	Opportunity, Inc.	accessdata.fda.gov
May 8, 1995	K945541	SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE	HKY	Substantially Equivalent	Rudolf Riester GmbH & Co. KG	accessdata.fda.gov
December 16, 1993	K931202	STERILIZATION WRAP-STERISHEET	FRG	Substantially Equivalent	Arjo Wiggins Medical, Inc.	accessdata.fda.gov
August 7, 1989	K890759	STRIP, STERILIZATION INDICATOR; STEAM	JOJ	Substantially Equivalent	Spsmedical Supply Corp.	accessdata.fda.gov
September 14, 1982	K822448	SCISSORS, VARIOUS	FZT	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
January 12, 1981	K802458	KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611	HFB	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
July 28, 1980	K801273	MAGILL CATHETER INTRO. FORCEPS	KOA	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
April 8, 1980	K800441	RUDD-CLINIC HEMORRHOIDAL FORCEPS	KOA	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
April 23, 1979	K790577	HEMORRHOIDAL LIGATOR	HCF	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
January 3, 1978	K772230	CANNULA, PERFUSION, FALLOPIAN TUBE	LKF	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
January 3, 1978	K772229	MINICLAMPS, STABILIZ., FALLOPIAN TUBE	HCZ	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
October 4, 1977	K771806	THOREK SCISSORS 7 1/4 & 10	FZT	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
July 27, 1977	K771344	GUSBERG HYSTERECTOMY CLAMP	HGC	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
February 24, 1977	K761334	MARCUSE TUBE CLAMPING FORCEPS, STRAIGHT	GEN	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
January 14, 1977	K770041	SCISSORS, STRABISMUS, 4 CURVED	HNF	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
January 14, 1977	K770040	SCISSORS, STRABIMUS, 4 STRAIGHT	HNF	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov
January 12, 1977	K770019	SCISSORS, IRIS	HNF	Substantially Equivalent	J. Sklar Mfg. Co., Inc.	accessdata.fda.gov

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Updated November 8, 2011. 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.