Data / Medical devices / Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE): 285 FDA-registered makers in 27 countries

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

285 establishments in 27 countries are registered with the FDA to make Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE, Class 1, 21 CFR 878.4820). 16 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 76 510(k) clearances under this code, the latest on February 20, 2015, and lists 27 recall events (1 Class I). FDA data exported November 3, 2026.

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

Makers by country

Country	Makers
United States	143
Germany	33
Switzerland	20
China	20
France	19
Ireland	6
India	5
Mexico	4
Japan	4
Italy	4
Malaysia	4
South Korea	3
United Kingdom	2
Poland	2
Costa Rica	2
Netherlands	2
Austria	2
Lithuania	1
Canada	1
Nicaragua	1
Dominican Republic	1
New Zealand	1
Pakistan	1
Brazil	1
Taiwan	1
Philippines	1
Israel	1

Makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

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	Class I	Source
Shalby Advanced Technologies, Inc.	El Dorado Hills, CA, United States	Manufacturer	7	August 15, 1996	0	0	api.fda.gov
Depuy Orthopaedics	Bridgewater, MA, United States	Manufacturer, Repackager or relabeler	4	January 5, 2005	0	0	api.fda.gov
Synthes GMBH	Zuchwil Solothurn, Switzerland	Specification developer	3	January 16, 2007	0	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	2	December 29, 1997	0	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer, Specification developer	2	March 20, 1996	3	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	2	January 5, 2005	2	0	api.fda.gov
The Anspach Effort, Inc.	Palm Bch Gdns, FL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	2	January 16, 2007	3	1	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	1	January 25, 1994	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	1	June 10, 1988	0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Raynham, MA, United States	Manufacturer	1	June 10, 1988	0	0	api.fda.gov
Mahe Medical Usa	Laramie, WY, United States	Complaint file establishment, Specification developer	1	January 20, 2011	0	0	api.fda.gov
Mcginley Orthopaedic Innovations, Inc	Casper, WY, United States	Complaint file establishment, Manufacturer, Specification developer	1	February 20, 2015	0	0	api.fda.gov
Medicon, E.G.	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer	1	April 23, 1997	0	0	api.fda.gov
Ortho Solutions UK Limited	Maldon Essex, United Kingdom	Complaint file establishment, Manufacturer, Specification developer	1	January 20, 2011	0	0	api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbH	Oberdorf, Baselland Basel-Landschaft, Switzerland	Manufacturer, Specification developer	1	January 5, 2005	0	0	api.fda.gov
Zimmer Trabecular Metal Technology, Inc.	Parsippany, NJ, United States	Manufacturer	1	May 26, 2005	0	0	api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)	Riviera Beach, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
3Spine, Inc.	Chattanooga, TN, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Aap Implantate AG	Berlin, Germany	Manufacturer	0		0	0	api.fda.gov
AB Ortopedijos Technika	Kaunas Kauno Apskritis, Lithuania	Manufacturer	0		0	0	api.fda.gov
Abnox AG	Cham Zug, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Acumed LLC	Hillsboro, OR, United States	Specification developer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Carlsbad, CA, United States	Manufacturer	0		0	0	api.fda.gov
American Surgical Company, LLC	Beverly, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
AMETEK Poland sp. z o.o.	Siechnice Dolnoslaskie, Poland	Contract manufacturer	0		0	0	api.fda.gov
AMF, Sarl	Lury sur Arnon Cher, France	Contract manufacturer	0		0	0	api.fda.gov
Amplitude	Valence Drome, France	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Arbutus Medical, Inc	Burnaby British Columbia, Canada	Manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Memphis	Lexington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
ARCH Medical Solutions - Seabrook	Seabrook, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Arthrosurface, Inc.	W Bridgewater, MA, United States	Manufacturer	0		0	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Axia Orthopedics	Portland, OR, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Alkem MedTech Pvt. Ltd.	Thane Maharashtra, India	Manufacturer	0		0	0	api.fda.gov
Alphatec Spine, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Arthrex California Technology, Incorporated	Santa Barbara, CA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Arthrex Logistic Center	Fort Myers, FL, United States	Manufacturer	0		0	0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	0		0	0	api.fda.gov
Arthrocare Corporation	Coyol Alajuela, Costa Rica	Manufacturer	0		0	0	api.fda.gov
Autocam Medical Devices (Suzhou) Co. Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Auxein medical Private limited	Sonipat Haryana, India	Manufacturer	0		0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Baeramed Instrumente GMBH	SCHWENNINGEN Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Benchmark Electronics, Inc.	Winona, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Bester Medical System SP. Z O. O.	Nowa Deba Podkarpackie, Poland	Contract manufacturer	0		0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		1	0	api.fda.gov
Bonebridge AG	Zug, Switzerland	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Bumueller GmbH	IRNDORF Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
C&A Tool Engineering, Inc. Auburn Plant	Auburn, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Canwell Medical Co., Ltd.	Jinhua Zhejiang, China	Contract manufacturer	0		0	0	api.fda.gov
Cefimeca	La Talaudiere Loire, France	Contract manufacturer	0		0	0	api.fda.gov
Centex Machining, Inc.	Round Rock, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Chongqing Orthopaedic Technology Institute Co., Ltd.	Chongqing, China	Manufacturer	0		0	0	api.fda.gov
Command Medical Nicaragua SA	Managua, Nicaragua	Contract manufacturer	0		0	0	api.fda.gov
Conmed Corporation	Utica, NY, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Corentec Co., Ltd.	Cheonan Si, Chungnam, South Korea	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Coulot Decolletage	CHATELLERAULT Vienne, France	Contract manufacturer	0		0	0	api.fda.gov
Culver Tool & Engineering	Plymouth, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Command Medical Products, LLC.	Ormond Beach, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Consolidated Medical Equipment Company	Chihuahua, Mexico	Contract manufacturer	0		0	0	api.fda.gov
Covidien	- Santo Domingo, Dominican Republic	Contract manufacturer	0		0	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	Manufacturer, Specification developer	0		0	0	api.fda.gov
Depuy Intl., Ltd.	Leeds, United Kingdom	Manufacturer, Specification developer	0		0	0	api.fda.gov
Depuy Spine, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji Limited	Dongguan City Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Dubourgel Grange	Fontaine Isere, France	Contract manufacturer	0		0	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	Specification developer	0		0	0	api.fda.gov
Eca Medical Instruments	Newbury Park, CA, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		1	0	api.fda.gov
Enztec Limited	CHRISTCHURCH Canterbury, New Zealand	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Ethicon, Inc.	CIUDAD JUAREZ Chihuahua, Mexico	Contract manufacturer	0		0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Extremity Medical, LLC	Parsippany, NJ, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
FH Industrie	QUIMPER Finistere, France	Manufacturer	0		0	0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Force Engineering Co.ltd	Utsunomiya Tochigi, Japan	Contract manufacturer	0		0	0	api.fda.gov
Frueh Verpackungstechnik AG	Fehraltorf Zurich, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	0	api.fda.gov
Gebr. Brasseler GMBH & Co. KG	LEMGO North Rhine-Westphalia, Germany	Contract manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Audubon, PA, United States	Manufacturer	0		0	0	api.fda.gov
Globus Medical, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
GM Dos Reis Industria E Comercio Ltda	Campinas Sao Paulo, Brazil	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Guangzhou Aquila Precise Tools Limited	Guangzhou City Guangdong, China	Contract manufacturer	0		0	0	api.fda.gov
Guizhou Zirui Technology Co., Ltd.	Tongzi County, Zunyi Guizhou, China	Manufacturer	0		0	0	api.fda.gov
Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0		0	0	api.fda.gov
Hager & Meisinger GMBH	NEUSS North Rhine-Westphalia, Germany	Contract manufacturer	0		0	0	api.fda.gov
Hermann Medizintechnik GMBH	FRIDINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
HG Medical GmbH	Raisting Bavaria, Germany	Contract manufacturer, Exporter to the US	0		0	0	api.fda.gov
High-Tech Quality MFG. Inc.	Salt Lake City, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
Hing Ka Yuen Health Technology (changzhou )co., Ltd	Changzhou Jiangsu, China	Manufacturer	0		0	0	api.fda.gov
HPF S.R.L.	Forgaria nel Friuli Friuli Venezia Giulia, Italy	Manufacturer	0		0	0	api.fda.gov
Huron Tool & Cutter Grinding	Farmingdale, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Hydrocision, Inc.	Billerica, MA, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
HyperFlex Medical Inc	Richmond, UT, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Imedicom Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0		0	0	api.fda.gov
In'tech Medical SAS	RANG DU FLIERS Pas-de-Calais, France	Contract manufacturer, Exporter to the US	0		0	0	api.fda.gov
Instru-Med Technologies	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Intai Technology Corp. Implants Business Unit	Taichung City, Taiwan	Contract manufacturer	0		0	0	api.fda.gov
In2Bones SAS	Saint-Priest Rhone, France	Exporter to the US, Specification developer	0		0	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0		0	0	api.fda.gov
Jiangsu Baide Medical Instrument Co.,ltd.	Zhangjiagang Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Jiangxi Vision Plus Medical Technology Co.,ltd	Nanchang Jiangxi, China	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Joimax GMBH	KARLSRUHE Baden-Wurttemberg, Germany	Exporter to the US, Manufacturer	0		0	0	api.fda.gov
Jabil Circuit (Shanghai) Ltd.	Shanghai, China	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc.	Auburn Hills, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Brandywine)	W Chester, PA, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Elmira)	Horseheads, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)	Bettlach Solothurn, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)	Hagendorf Solothurn, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Jabil Switzerland Manufacturing GmbH (Le Locle)	Le Locle Neuchatel, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Jabil Tuttlingen Manufacturing GmbH	Tuttlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
K2M, Inc.	Leesburg, VA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Karl Storz Se & Co KG	TUTTLINGEN Baden-Wurttemberg, Germany	Specification developer	0		0	0	api.fda.gov
Karl Storz Se & Co. KG	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Kaul Medizintechnik GMBH	Dierdorf Rhineland-Palatinate, Germany	Complaint file establishment, Manufacturer, Specification developer	0		0	0	api.fda.gov
Keystone Manufacturing	Kalamazoo, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Ksi Co., Ltd.	Gotemba Shizuoka, Japan	Contract manufacturer	0		0	0	api.fda.gov
Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Kimball Solutions - Indianapolis	Indianapolis, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Kreidler Medizintechnik GmbH	Wurmlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0		0	0	api.fda.gov
Limacorporate S.p.A.	Villanova di San Daniele Udine, Italy	Manufacturer	0		0	0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
LinkBio Corp.	Dover, NJ, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Mac Machine Company	Baltimore, MD, United States	Contract manufacturer	0		0	0	api.fda.gov
Maillefer Instruments Holding Sarl	BALLAIGUES Vaud, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Maitland Engineering	South Bend, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Manman Manufacturing Company Private Limited	Pune Maharashtra, India	Manufacturer	0		0	0	api.fda.gov
Mci Medical Concept Innovation Inc.	Sunrise, FL, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Mectron S.P.A.	CARASCO Genova, Italy	Manufacturer	0		0	0	api.fda.gov
Medcare Solutions GMBH	Emmingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Medical Bees GMBH	Emmingen-Liptingen Baden-Wurttemberg, Germany	Manufacturer	0		0	0	api.fda.gov
Medicatechnologie	CHARTRES-DE-BRETAGNE Ille-et-Vilaine, France	Contract manufacturer	0		0	0	api.fda.gov
Medizintechnik Sattler GMBH	Koenigsee Thuringia, Germany	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Medos International Sarl	Le Locle Neuchatel, Switzerland	Specification developer	0		0	0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Medtronic Powered Surgical Solutions	Fort Worth, TX, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Humacao	Humacao, PR, United States	Manufacturer	0		0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Manufacturer, Repackager or relabeler	0		0	0	api.fda.gov
Medtronic Sofamor Danek Usa, Inc.	Memphis, TN, United States	Specification developer	0		1	0	api.fda.gov
Medtronic Xomed, Inc.	Jacksonville, FL, United States	Manufacturer	0		0	0	api.fda.gov
Microaire Surgical Instruments LLC	Charlottesville, VA, United States	Manufacturer	0		0	0	api.fda.gov
Microport Orthopedics Inc.	Arlington, TN, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Reprocessor	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
MPS Micro Precision Systems AG	Biel-Bienne Bern, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Medline ReNewal	Redmond, OR, United States	Repackager or relabeler, Reprocessor	0		0	0	api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., Ltd	Changzhou Jiangsu, China	Manufacturer	0		0	0	api.fda.gov
Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, Costa Rica	Manufacturer	0		0	0	api.fda.gov
Metal Components LLC	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Nakamura Dental Handpiece MFG. Co., Ltd.	ITABASHI-KU Tokyo, Japan	Manufacturer	0		0	0	api.fda.gov
Nakanishi Inc.	Kanuma Tochigi, Japan	Manufacturer	0		0	0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Nouvag AG	GOLDACH Sankt Gallen, Switzerland	Manufacturer	0		0	0	api.fda.gov
Novastep	RENNES Bretagne, France	Manufacturer	0		0	0	api.fda.gov
NTOC medische techniek B.V	Oss Noord-Brabant, Netherlands	Contract manufacturer	0		0	0	api.fda.gov
Nypro Inc (Maple Grove)	Maple Grove, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Oeb S.R.L.	Camposanto Modena, Italy	Contract manufacturer	0		0	0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Orthopedic Sciences, Inc	Overland Park, KS, United States	Specification developer	0		0	0	api.fda.gov
Osteofit LLC	Fairfield, NJ, United States	Specification developer	0		0	0	api.fda.gov
Osteomed	Addison, TX, United States	Manufacturer, Specification developer	0		0	0	api.fda.gov
Osteoremedies, LLC	Memphis, TN, United States	Specification developer	0		0	0	api.fda.gov
Oury-Guye & Fils	NOGENT Haute-Marne, France	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Pfau Medizinische Instrumente GMBH	WANFRIED Hesse, Germany	Contract manufacturer	0		0	0	api.fda.gov
Phen'x Technologies	Chassieu Auvergne-Rhone-Alpes, France	Contract manufacturer	0		0	0	api.fda.gov
Phoenix Medical Products, Inc.	Mountain City, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Pivot - Edm	La Vista, NE, United States	Contract manufacturer	0		0	0	api.fda.gov
Precision Edge Surgical Products Company	Sault Sainte Marie, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex, Inc.	Irvine, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Ptumedical GMBH	Spaichingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Puracon GMBH	Rosenheim Bavaria, Germany	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
Pivot Hawks Manila, Inc.	Sta Rosa Laguna, Philippines	Contract manufacturer	0		0	0	api.fda.gov
Pivot International	Lenexa, KS, United States	Specification developer	0		0	0	api.fda.gov
Precision Edge Surgical Products Co LLC	Boyne City, MI, United States	Manufacturer for export	0		0	0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	0	api.fda.gov
Pro-Dex Inc	Tustin, CA, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
ProMed Concepts, LLC	Brighton, TN, United States	Contract manufacturer	0		0	0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	0	api.fda.gov
Rayco Steel Process, Inc.	Warsaw, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Renovo, Inc.	Bend, OR, United States	Reprocessor	0		0	0	api.fda.gov
Richard Wolf GMBH	KNITTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	0	api.fda.gov
Ringele AG	Pratteln Basel-Landschaft, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Ruetschi Technology AG	Muntelier Fribourg, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
RZ Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Saeshin Precision Co., Ltd.	Daegu, South Korea	Manufacturer	0		0	0	api.fda.gov
Satelec-Acteon Group	MERIGNAC Gironde, France	Manufacturer	0		0	0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	0	api.fda.gov
Selenium Medical S.A.S.	La Rochelle Charente-Maritime, France	Contract manufacturer	0		0	0	api.fda.gov
Serf	DECINES CHARPIEU Rhone, France	Manufacturer	0		0	0	api.fda.gov
Shaanxi Ansen Medical Technology Development Co.,ltd.	Xi'an Shaanxi, China	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Shanghai Bojin Medical Instrument Co., Ltd.	Shanghai, China	Manufacturer	0		0	0	api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.	Shanghai, China	Manufacturer	0		0	0	api.fda.gov
SIGN Fracture Care International	Richland, WA, United States	Manufacturer	0		0	0	api.fda.gov
Simon SAS	Bayeux Calvados, France	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Oklahoma City, OK, United States	Manufacturer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Andover, MA, United States	Specification developer	0		0	0	api.fda.gov
Smith & Nephew Inc.	Mansfield, MA, United States	Manufacturer, Specification developer	0		1	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Smithstown Light Engineering	Shannon Clare, Ireland	Contract manufacturer	0		0	0	api.fda.gov
SMT Schilling Metalltechnik GMBH	MUHLHEIM Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Sphinx Tools Ltd	Derendingen Solothurn, Switzerland	Contract manufacturer	0		0	0	api.fda.gov
Spierings Orthopaedics B.V.	NIJMEGEN Gelderland, Netherlands	Manufacturer	0		0	0	api.fda.gov
Spineart SA	Plan-les-Ouates, Switzerland	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Staan Biomed Engineering Private Limited	COIMBATORE Tamil Nadu, India	Manufacturer	0		0	0	api.fda.gov
Steripack Usa (limited) LLC	Lakeland, FL, United States	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Simpang Ampat Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Perai Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Straits Orthopaedics (MFG) Sdn Bhd	Bandar Cassia Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
STRYKER GmbH	SELZACH Solothurn, Switzerland	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Stryker Ireland Ltd., Instruments Division	CARRIGTWOHILL, CO.CORK Munster, Ireland	Contract manufacturer	0		0	0	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Stryker Manufacturing Kalamazoo	Portage, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Stryker Puerto Rico, LLC.	Arroyo, PR, United States	Contract manufacturer	0		0	0	api.fda.gov
Stryker Trauma GMBH	SCHOENKIRCHEN Schleswig-Holstein, Germany	Contract manufacturer	0		0	0	api.fda.gov
Surgical Instrument Manufacturers, LLC	Fenton, MO, United States	Contract manufacturer	0		0	0	api.fda.gov
Suzhou Microport Orthorecon Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc	Claypool, IN, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
Symmetry Medical Manufacturing Inc.	Lansing, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	0		0	0	api.fda.gov
Societe Marnaise D'Applications Orthopediques (SMAO) Sarl	Villiers Le Sec Haute-Marne, France	Contract manufacturer	0		0	0	api.fda.gov
Stryker (Suzhou) Medical Technology Co.,Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Stryker Instruments	Portage, MI, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork(County), Ireland	Specification developer	0		0	0	api.fda.gov
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou Jiangsu, China	Contract manufacturer	0		0	0	api.fda.gov
Symmetry Medical Malaysia Sdn Bhd (758243-M)	Bayan Lepas Pulau Pinang, Malaysia	Contract manufacturer	0		0	0	api.fda.gov
Synthes GMBH	Selzach Solothurn, Switzerland	Manufacturer	0		0	0	api.fda.gov
T & L Sharpening, Inc.	Indiana Beach, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
T.A.G. Medical Products Corporation Ltd	Bar-Lev Northern, Israel	Contract manufacturer	0		0	0	api.fda.gov
Takumi Precision Engineering Ltd	Limerick Limerick(County), Ireland	Contract manufacturer	0		0	0	api.fda.gov
Techtronic Industries Medical	Anderson, SC, United States	Contract manufacturer	0		0	0	api.fda.gov
Tecomet, Inc.	Kenosha, WI, United States	Contract manufacturer	0		0	0	api.fda.gov
Theken Companies, LLC	Akron, OH, United States	Specification developer	0		0	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	0		0	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	0		0	0	api.fda.gov
Trax Surgical, Inc.	Stoughton, MA, United States	Manufacturer	0		0	0	api.fda.gov
Treace Medical Concepts, Inc.	Ponte Vedra, FL, United States	Manufacturer	0		0	0	api.fda.gov
Triangle Machine, Inc.	South Bend, IN, United States	Manufacturer	0		0	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Turner Medical Inc.	Athens, AL, United States	Contract manufacturer	0		0	0	api.fda.gov
Tegra Medical	Hernando, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Teufel & Gerlach GmbH	Tuttlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Tornier S.A.S.	Montbonnot Saint-Martin Isere, France	Manufacturer	0		0	0	api.fda.gov
VCN Technologies	SAINT-PRIEST Auvergne-Rhone-Alpes, France	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, Inc.	Grand Rapids, MI, United States	Contract manufacturer	0		0	0	api.fda.gov
Viant Medical, LLC	Fort Wayne, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
W&H Dentalwerk Buermoos GMBH	BUERMOOS Salzburg, Austria	Contract manufacturer, Exporter to the US, Manufacturer	0		1	0	api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2	BUERMOOS Salzburg, Austria	Contract manufacturer, Exporter to the US, Manufacturer	0		0	0	api.fda.gov
W+S Solutions GMBH	Tuttlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Warsaw Orthopedic, Inc.	Warsaw, IN, United States	Manufacturer	0		0	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	0		0	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	0		0	0	api.fda.gov
Waldemar Link GmbH & Co. KG	Norderstedt Schleswig-Holstein, Germany	Manufacturer	0		0	0	api.fda.gov
Wenzler Medizintechnik GmbH	Frittlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	0	api.fda.gov
Xtant Medical Holdings, Inc.	Belgrade, MT, United States	Repackager or relabeler, Specification developer	0		0	0	api.fda.gov
Zimmer GMBH	WINTERTHUR Zurich, Switzerland	Manufacturer	0		0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	0		1	0	api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua Zhejiang, China	Manufacturer	0		0	0	api.fda.gov

Updated February 20, 2015. 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.