Data / Medical devices / Germany / Smi Medical Instruments GMBH & Co.kg

Smi Medical Instruments GMBH & Co.kg: FDA-registered device maker in NEUHAUSEN OB ECK Baden-Wurttemberg, Germany, 5 510(k) clearances

Name: Smi Medical Instruments GMBH & Co.kg FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Smi Medical Instruments GMBH & Co.kg is registered with the FDA (registration 8010871) in NEUHAUSEN OB ECK Baden-Wurttemberg, Germany. It lists 24 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 17, 2022. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Smi Medical Instruments GMBH & Co.kg

FDA registration number: 8010871
FEI number: 6166
Address: Robert Bosch Strasse 36, NEUHAUSEN OB ECK Baden-Wurttemberg, Germany, D-78579
Owner or operator: SMI MEDICAL INSTRUMENTS GMBH & CO KG (8010871)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: February 8, 1988
Registered through: 2026
Brand names listed: 3795-01BP, 80100081

Devices it lists

Device	Product code	Class	Role	Source
Cannula, Surgical, General & Plastic Surgery	GEA	1	Contract manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Contract manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Contract manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Contract manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Elevator, Surgical, General & Plastic Surgery	GEG	1	Contract manufacturer	accessdata.fda.gov
Forceps	HTD	1	Contract manufacturer	accessdata.fda.gov
Forceps, General & Plastic Surgery	GEN	1	Contract manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Contract manufacturer	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Contract manufacturer	accessdata.fda.gov
Instrument, Cutting, Orthopedic	HTZ	1	Contract manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer	accessdata.fda.gov
Instrument, Microsurgical	GZX	1	Contract manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Contract manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Repackager or relabeler	accessdata.fda.gov
Mallet, Surgical, General & Plastic Surgery	GFJ	1	Contract manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Repackager or relabeler	accessdata.fda.gov
Punch, Surgical	LRY	1	Contract manufacturer	accessdata.fda.gov
Rasp, Surgical, General & Plastic Surgery	GAC	1	Contract manufacturer	accessdata.fda.gov
Retractor	GAD	1	Contract manufacturer	accessdata.fda.gov
Rongeur	HTX	1	Contract manufacturer	accessdata.fda.gov
Scissors, General, Surgical	LRW	1	Contract manufacturer	accessdata.fda.gov
Scissors, Orthopedic, Surgical	HRR	1	Contract manufacturer	accessdata.fda.gov
Speculum, Ent	EPY	1	Contract 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
November 17, 2022	K213042	Supra Non-Stick Bipolar Forceps	GEI	Substantially Equivalent	Guenter Bissinger Medizintechnik GmbH	accessdata.fda.gov
April 5, 2018	K172368	Bipolar Micro-Coagulation Forceps	GEI	Substantially Equivalent	Gunter Bissinger Medizintechnik GmbH	accessdata.fda.gov
July 29, 2005	K051429	CLARIS NON-STICK BIPOLAR FORCEPS	GEI	Substantially Equivalent	Guenter Bissinger Medizintechnik GmbH	accessdata.fda.gov
August 19, 1997	K964229	REGULUS NAVIGATOR	HAW	Substantially Equivalent	Compass Intl., Inc.	accessdata.fda.gov
December 5, 1994	K945474	SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDER	GCJ	Substantially Equivalent	Scanlan Intl., Inc.	accessdata.fda.gov

Compare with other makers

Updated November 17, 2022. 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.