Data / Medical devices / Motor, Surgical Instrument, Ac-Powered

Motor, Surgical Instrument, Ac-Powered (GEY): 108 FDA-registered makers in 22 countries

Name: FDA-registered makers of Motor, Surgical Instrument, Ac-Powered
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

108 establishments in 22 countries are registered with the FDA to make Motor, Surgical Instrument, Ac-Powered (product code GEY, Class 1, 21 CFR 878.4820). 5 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on May 17, 2005, and lists 13 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: GEY
Device class: 1
Regulation: 878.4820
Medical specialty: General, Plastic Surgery

Makers by country

Country	Makers
United States	53
Germany	10
Switzerland	7
China	6
South Korea	5
France	4
United Kingdom	3
Malaysia	3
Mexico	2
Brazil	2
Austria	2
Turkey	1
Spain	1
Sweden	1
Belgium	1
Paraguay	1
India	1
Italy	1
Japan	1
Philippines	1
Poland	1
Canada	1

Makers of Motor, Surgical Instrument, Ac-Powered

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	1	November 14, 2001	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer, Specification developer	1	May 17, 2005	3	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	1	August 14, 1996	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer	1	August 14, 1996	0	api.fda.gov
Synthes GMBH	Zuchwil Solothurn, Switzerland	Specification developer	1	May 5, 1997	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Aseptico, Inc.	Woodinville, WA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Manufacturer	0		0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	api.fda.gov
Bien-Air Dental SA	Biel/Bienne Bern, Switzerland	Manufacturer	0		0	api.fda.gov
Biomet Microfixation	Jacksonville, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
Biopark Medikal Sanayi Ve Ticaret Anonim Sirketi	Kocaeli, Turkey	Manufacturer	0		0	api.fda.gov
Baz Biomedic Co., Ltd.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Carefusion 2200, Inc.	Vernon Hills, IL, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Celestica	Valencia Valencia(Province), Spain	Contract manufacturer	0		0	api.fda.gov
Cochlear Bone Anchored Solutions AB	Molnlycke Vastra Gotaland, Sweden	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Cole Instruments	Alpharetta, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Consolidated Medical Equipment Company	Chihuahua, Mexico	Contract manufacturer	0		0	api.fda.gov
De Soutter Medical Ltd.	ASTON CLINTON Buckinghamshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer, Specification developer	0		0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Dimeda Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Devroye Instruments SRL	Etterbeek Brussels-Capital Region, Belgium	Manufacturer	0		0	api.fda.gov
Electronique Du Mazet	Le Mazet Saint Voy Auvergne-Rhone-Alpes, France	Manufacturer	0		0	api.fda.gov
Elliquence LLC	Baldwin, NY, United States	Specification developer	0		0	api.fda.gov
Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Faga Medical Industria De Equipamentos E Instrumentos Medico Hospitalares Ltda Me	Bauru Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Focus Medical, LLC.	Bethel, CT, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Guangzhou Ajax Medical Equipment Co Ltd	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Highridge Medical, LLC	Westminster, CO, United States	Specification developer	0		0	api.fda.gov
I Brain Robotics Inc	Melbourne, FL, United States	Manufacturer	0		0	api.fda.gov
Imedicom Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0		0	api.fda.gov
Jeisys Medical Inc.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co KG	TUTTLINGEN Baden-Wurttemberg, Germany	Specification developer	0		0	api.fda.gov
Karl Storz Se & Co. KG	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co. KG	NEUHAUSEN OBECK Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Lifenet Health	Virginia Beach, VA, United States	Contract manufacturer	0		0	api.fda.gov
LifeNet Health	Virginia Bch, VA, United States	Contract manufacturer	0		0	api.fda.gov
LifeNet Health	Plainfield, IN, United States	Contract manufacturer	0		0	api.fda.gov
LifeNet Health Northwest	Renton, WA, United States	Contract manufacturer	0		0	api.fda.gov
Maillefer Instruments Holding Sarl	BALLAIGUES Vaud, Switzerland	Contract manufacturer	0		0	api.fda.gov
Mamba Instruments S.A.	Asuncion, Paraguay	Manufacturer	0		0	api.fda.gov
Manman Manufacturing Company Private Limited	Pune Maharashtra, India	Manufacturer	0		0	api.fda.gov
Mcginley Orthopaedic Innovations, Inc	Casper, WY, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0		0	api.fda.gov
Meta Ergonomica S.R.L.	Turbigo Milano, Italy	Manufacturer	0		0	api.fda.gov
Metapharm Co., Ltd	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
MILLENNIUM MEDICAL TECHNOLOGIES INC./DBA Cellmyx	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
MME Willow Lake	Vadnais Hts, MN, United States	Contract manufacturer	0		0	api.fda.gov
Moria S.A.	MASSY Hauts-de-Seine, France	Specification developer	0		0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Reprocessor	0		0	api.fda.gov
Metal Process	Montevrain Ile-de-France, France	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Moria S.A	Bourbon l'Archambault Allier, France	Exporter to the US, Manufacturer	0		0	api.fda.gov
Nakanishi Inc.	Kanuma Tochigi, Japan	Manufacturer	0		0	api.fda.gov
National Advanced Endoscopy Devices, Inc.	Canoga Park, CA, United States	Manufacturer	0		0	api.fda.gov
Ningbo Advan Electrical Co.,ltd	Cixi City Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Nouvag AG	GOLDACH Sankt Gallen, Switzerland	Manufacturer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Osseotouch LLC	Fairhope, AL, United States	Manufacturer for export	0		0	api.fda.gov
Olive Branch Distribution Center	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Pro-Dex, Inc.	Irvine, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		2	api.fda.gov
Pivot Hawks Manila, Inc.	Sta Rosa Laguna, Philippines	Contract manufacturer	0		0	api.fda.gov
Pivot International	Lenexa, KS, United States	Specification developer	0		0	api.fda.gov
Pro-Dex Inc	Tustin, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Quintenz Hybridtechnik GMBH	Neuried Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
Razek Equipamentos Ltda	Sao Carlos Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Rex Implants, Inc	Columbus, OH, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Richard Wolf GMBH	KNITTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Saeshin Precision Co., Ltd.	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Shenzhen Jinlichang Electronic Technology Co.ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Shenzhen Soga Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Steripack Medical Poland SP. Z O.O.	Jelcz-Laskowice Dolnoslaskie, Poland	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Complaint file establishment, Specification developer	0		0	api.fda.gov
Stryker Manufacturing Kalamazoo	Portage, MI, United States	Contract manufacturer	0		0	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	Manufacturer	0		0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbH	Oberdorf, Baselland Basel-Landschaft, Switzerland	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Techtronic Industries Medical	Anderson, SC, United States	Contract manufacturer	0		0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Manufacturer, Specification developer	0		3	api.fda.gov
Turnxon Precision Co., Ltd	Dongguan Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Vision Medical Inc	Glen Mills, PA, United States	Manufacturer	0		0	api.fda.gov
W&H Dentalwerk Buermoos GMBH	BUERMOOS Salzburg, Austria	Contract manufacturer, Manufacturer	0		0	api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2	BUERMOOS Salzburg, Austria	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Zepf Medical Instruments GMBH	SEITINGEN-OBERFLACHT Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Zethon Ltd	ASTON CLINTON Buckinghamshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Zimmer Cas	Montreal, Quebec, Canada	Manufacturer	0		0	api.fda.gov
Zimmer Surgical SA	1228 Plan Les Ouates Geneve, Switzerland	Manufacturer	0		0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	api.fda.gov

Updated May 17, 2005. 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.