Data / Medical devices / Germany / Hebumedical GMBH

Hebumedical GMBH: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 5 510(k) clearances

Name: Hebumedical GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hebumedical GMBH is registered with the FDA (registration 9611112) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 228 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 14, 2013. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9611112
FEI number: 3008782585
Address: Badstrasse 8, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator: HEBUMEDICAL GMBH (8010320)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: May 9, 1979
Registered through: 2027
Brand names listed: 17-1090TC, 17-1091TC, 17-1092TC, 18-1832A-TC, 8mm Osteotome straight, AMPUTATING KNIVES, AND OTHERS, APPLYING AND REMOVING FORCEP and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Contract manufacturer	accessdata.fda.gov
Accessories, Catheter	KGZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract manufacturer	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Repackager or relabeler	accessdata.fda.gov
Adenotome	KBH	1	Manufacturer	accessdata.fda.gov
Amniotome	HGE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applier, Hemostatic Clip	HBT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Applier, Surgical, Clip	GDO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Arthroscope	HRX	2	Repackager or relabeler	accessdata.fda.gov
Bar, Preformed	EHO	1	Manufacturer	accessdata.fda.gov
Basin, Emesis	FNY	1	Manufacturer	accessdata.fda.gov
Bistoury, Tracheal	KCC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Block, Cutting, Ent, Non-Sterile	NNR	1	Manufacturer	accessdata.fda.gov
Caliper	KTZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Caliper, Ophthalmic	HOE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Camera, Cine, Endoscopic, Without Audio	FWL	1	Manufacturer	accessdata.fda.gov
Camera, Television, Microsurgical, Without Audio	FWD	1	Contract manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Carrier, Ligature	GEJ	1	Manufacturer	accessdata.fda.gov
Carver, Wax, Dental	EIK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Chisel, Middle-Ear	JYE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Chisel, Nasal	KAN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Chisel, Surgical, Manual	FZO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp	HXD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Cannula	FKC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Circumcision	HFX	2	Contract manufacturer	accessdata.fda.gov
Clamp, Non-Electrical	FFN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Ossicle Holding	JYF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Penile	FHA	1	Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Uterine	HGC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Clip, Removable (Skin)	FZQ	1	Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Repackager or relabeler	accessdata.fda.gov
Contractor, Surgical	FZR	1	Manufacturer	accessdata.fda.gov
Curette	HTF	1	Contract manufacturer	accessdata.fda.gov
Curette, Adenoid	KBJ	1	Manufacturer	accessdata.fda.gov
Curette, Ear	JYG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Curette, Nasal	KAP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Curette, Ophthalmic	HNZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Contract manufacturer	accessdata.fda.gov
Curette, Surgical, General Use	FZS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Curette, Uterine	HCY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cutter, Surgical	FZT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cutter, Wire	HXZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Depressor, Metal Tongue, Surgical	KBL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Locking, For Intestinal Clamp	FFR	1	Manufacturer	accessdata.fda.gov
Dilator, Cervical, Fixed Size	HDQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dilator, Lachrymal	HNW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dilator, Tracheal	KCG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Dissector, Tonsil	KBM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Contract manufacturer	accessdata.fda.gov
Duodenoscope And Accessories, Flexible/Rigid	FDT	2	Repackager or relabeler	accessdata.fda.gov
Dynamometer, Nonpowered	HRW	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer	accessdata.fda.gov
Elevator	HTE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elevator, Ent	KAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Excavator, Ear	JYH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Contract manufacturer	accessdata.fda.gov
Extractor	HWB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Gynecological	HFB	1	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Dressing, Dental	EFL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Ent	KAE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Rongeur, Surgical	EMH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Forceps, Surgical, Gynecological	HCZ	2	Contract manufacturer	accessdata.fda.gov
Forceps, Wire Holding	HYA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Fork, Tuning	GWX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gag, Mouth	KBN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Contract manufacturer	accessdata.fda.gov
Gauge, Depth, Instrument, Dental	EIL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauge, Measuring	JYJ	1	Contract manufacturer	accessdata.fda.gov
Goniometer, Nonpowered	KQW	1	Manufacturer	accessdata.fda.gov
Gouge, Nasal, Ent	KAQ	1	Manufacturer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Halter, Head, Traction	HSS	1	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Handpiece (Brace), Drill	HBD	1	Contract manufacturer	accessdata.fda.gov
Hemostat	HRQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Holder, Needle; Orthopedic	HXK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hook, Microsurgical Ear	JYL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hook, Tracheal	KCH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Hysteroscope Accessories	NWW	1	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Bending Or Contouring	HXP	1	Manufacturer	accessdata.fda.gov
Instrument, Cast Application/Removal, Manual	LGG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Cast Removal, Ac-Powered	LGH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Catheter, Punch	FEX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Ent Manual Surgical	LRC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Ligature Passing And Knot Tying	HCF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Manual, General Obstetric-Gynecologic	KOH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Manual, Specialized Obstetric-Gynecologic	KNA	2	Contract manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Knife, Amputation	GDN	1	Manufacturer	accessdata.fda.gov
Knife, Ear	JYO	1	Manufacturer	accessdata.fda.gov
Knife, Ent	KTG	1	Manufacturer	accessdata.fda.gov
Knife, Nasal	KAS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Knife, Orthopedic	HTS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Knife, Surgical	EMF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Knife, Tonsil	KBQ	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscopic Accessories, Gynecologic	NWV	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Laryngoscope, Rigid	CCW	1	Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer	accessdata.fda.gov
Loop, Wire	JYQ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Magnet, Permanent	HPN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mallet	HXL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Marker, Skin	FZZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mediastinoscope, Surgical	EWY	2	Contract manufacturer	accessdata.fda.gov
Mirror, Ent	KAI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mirror, Mouth	EAX	1	Manufacturer	accessdata.fda.gov
Mobilizer, Ent	KAJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Reusable	GDM	1	Manufacturer	accessdata.fda.gov
Needle, Gastro-Urology	FHR	1	Manufacturer	accessdata.fda.gov
Needle, Suturing, Reusable	GDL	1	Manufacturer	accessdata.fda.gov
Nipper, Malleus	JYR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Contract manufacturer	accessdata.fda.gov
Osteotome	HWM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Osteotome, Manual	GFI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Otoscope	ERA	1	Contract manufacturer	accessdata.fda.gov
Packer, Uterine	HDM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Passer	HWQ	1	Manufacturer	accessdata.fda.gov
Pick, Microsurgical Ear	JYT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pinwheel	GWY	1	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Contract manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Press, Vein	JYW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Probe	HXB	1	Contract manufacturer	accessdata.fda.gov
Probe And Director, Gastro-Urology	FGM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Probe, Ent	KAK	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Probe, Lachrymal	HNL	1	Manufacturer	accessdata.fda.gov
Probe, Rectal, Non-Powered	EXX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Punch, Antrum	KAW	1	Manufacturer	accessdata.fda.gov
Punch, Ent	KTF	1	Manufacturer	accessdata.fda.gov
Punch, Surgical	LRY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rack, Clip	HBR	1	Manufacturer	accessdata.fda.gov
Rasp	HTR	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rasp, Ear	JYY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rasp, Nasal	KBA	1	Manufacturer	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Remover, Crown	EIS	1	Manufacturer	accessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-Type	HHF	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, Ent	KAL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Manufacturer	accessdata.fda.gov
Retractor, Non-Self-Retaining	FGN	1	Manufacturer	accessdata.fda.gov
Retractor, Ophthalmic	HNI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, Self-Retaining	FFO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Retractor, Self-Retaining, For Neurosurgery	GZT	2	Contract manufacturer	accessdata.fda.gov
Retractor, Vaginal	HDL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Ring Cutter	FNS	1	Manufacturer	accessdata.fda.gov
Ring, Laparotomy	FHI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rod, Measuring Ear	JYZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Saw	HSO	1	Manufacturer	accessdata.fda.gov
Saw, Electrically Powered	DWI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Saw, Manual And Accessories	GDR	1	Manufacturer	accessdata.fda.gov
Saw, Nasal	KBC	1	Manufacturer	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Manufacturer	accessdata.fda.gov
Scissors, Ear	JZB	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Scissors, Episiotomy	HDK	1	Manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Scissors, Nasal	KBD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Scissors, Surgical Tissue, Dental	EGN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Scissors, Umbilical	HDJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Scoop	FHL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Contract manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Contract manufacturer	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Repackager or relabeler	accessdata.fda.gov
Snare, Ear	JZD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Snare, Nasal	KBE	1	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Snare, Tonsil	KBZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sound, Urethral, Metal Or Plastic	FBX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sound, Uterine	HHM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Source, Carrier, Fiberoptic Light	EQH	1	Manufacturer	accessdata.fda.gov
Spatula, Surgical, General & Plastic Surgery	GAF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Specula Accessories	FXG	1	Contract manufacturer	accessdata.fda.gov
Specula, Ophthalmic	HNC	1	Manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Speculum, Non-Illuminated	FXE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Speculum, Rectal	FFQ	1	Manufacturer	accessdata.fda.gov
Speculum, Vaginal, Metal	HDF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Spud, Ophthalmic	HNA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Manufacturer	accessdata.fda.gov
Stripper, Surgical	HRT	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stripper, Vein, Reusable	GAI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stylet, Surgical, General & Plastic Surgery	GAH	1	Manufacturer	accessdata.fda.gov
Support, Patient Position	CCX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Ent	KCP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tamp	HXG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tap, Bone	HWX	1	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tenaculum, Uterine	HDC	2	Contract manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Exporter to the US	accessdata.fda.gov
Tonsillectome	KCA	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Trocar, Ent	KTE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Trocar, Tracheal	KCI	1	Manufacturer	accessdata.fda.gov
Tube, Ear Suction	JZF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Twister, Wire	HXS	1	Contract manufacturer, Manufacturer	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
May 14, 2013	K123077	VASCULAR CLAMPS	DXC	Substantially Equivalent	Hebumedical GmbH	accessdata.fda.gov
March 31, 1998	K974493	FIEGERT ENDOTECH FLEXIBLE FIBEROPTIC ENDOSCOPES, FIEGERT ENDOTECH FLEXIBLE VIDEO-ENDOSCOPES	FDS	Substantially Equivalent	Fiegert-Endotech Medizintechnik GmbH	accessdata.fda.gov
September 8, 1995	K951990	LAPAROSCOPE, ROD-LENS VIEWING AND OPERATING ENDOSCOPE	GCJ	Substantially Equivalent	Schoelly Technologies, 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
February 1, 1995	K943426	ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE	HRX	Substantially Equivalent	Schoelly Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 14, 2013. 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.