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Data / Medical devices / Clamp, Surgical, General & Plastic Surgery

Clamp, Surgical, General & Plastic Surgery (GDJ): 209 FDA-registered makers in 24 countries

209 establishments in 24 countries are registered with the FDA to make Clamp, Surgical, General & Plastic Surgery (product code GDJ, Class 1, 21 CFR 878.4800). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on May 2, 2016, and lists 6 recall events (0 Class I). FDA data exported November 2, 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.

Product code
GDJ
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States65
Pakistan55
Germany44
China12
France6
India4
United Kingdom3
Malaysia2
Mexico2
Switzerland2
Poland1
Dominican Republic1
South Africa1
Taiwan1
Honduras1
Brazil1
Russia1
South Korea1
Canada1
United Arab Emirates1
Latvia1
Sweden1
Hungary1
Belgium1

Makers of Clamp, Surgical, General & Plastic Surgery

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler2December 15, 1978000api.fda.gov
CovidienNorth Haven, CT, United StatesRepackager or relabeler, Specification developer1April 9, 1990000api.fda.gov
CovidienPonce, PR, United StatesManufacturer1April 9, 1990000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1February 5, 1986020api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1February 5, 1986000api.fda.gov
A. Milazzo Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aesculap Chifa SP. Z O.O.NOWY TOMYSL Wielkopolskie, PolandContract manufacturer0000api.fda.gov
AlframedSialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Alira Medical Devices LLCRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
AmplitudeValence Drome, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Armatech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Asol Co.,ltdhuaian Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Bauer Und Haselbarth-Chirurg GMBHELLERAU Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Borvo Medical, Inc.Mountain View, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Buraq Surgical Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Buxton Biomedical, Inc.East Hanover, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Blink Medical LTDSolihull, United KingdomManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Health Microport Medical Device Co.,ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer0000api.fda.gov
Coba Biomedical Pty (ltd)Bloemfontein Free State, South AfricaContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Conqueror Medical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
DIME-PACK S. De R.L. De C.V.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
DTR Medical LtdSwansea, United KingdomManufacturer0000api.fda.gov
Dufner Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Denzel Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Eisenhut Instrumente GMBHFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Elmed Instruments (pvt). Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Elmed, Inc.Glendale Heights, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Eltek Instruments (pvt.) Ltd.Sialkot Punjab, PakistanContract manufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Endo Tech InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
F&M Plastics, Inc.Osceola, WI, United StatesContract manufacturer0000api.fda.gov
Fetzer Medical GMBH & Co.kgTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Fetzer Surgical, LLCScottsdale, AZ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Finix Industrial Co., Ltd.Chang Hua City Changhua, TaiwanManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
G.A. Surgical (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Geomed Medizin-Technik GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Georg Alber GMBH & Co. KGRENQUISHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hazel EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Hebumedical GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Hexamed Pvt LtdSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Huaian Frimen Co., LtdHuaian Jiangsu, ChinaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Hotry Co.,LtdBeijing, ChinaExporter to the US, Manufacturer0000api.fda.gov
Iaa Surgical Instruments CoSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
In'tech Medical SASRANG DU FLIERS Pas-de-Calais, FranceContract manufacturer, Exporter to the US0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Integra Microfrance SASSAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FranceManufacturer, Repackager or relabeler0000api.fda.gov
ITM Industria de Tecnologias Medicas LTDACANOAS Rio Grande do Sul, BrazilManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
J & J Instruments, LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Jay-MedSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.Ji 'an Jiangxi, ChinaManufacturer0000api.fda.gov
Julius Wirth LLCEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Johnson & Johnson MEDICAL GmbHNORDERSTEDT Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
K.T. SurgicoSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Kapp Surgical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
Karl Klappenecker GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Katena Products, Inc.Parsippany, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Katena Products, Inc.Randolph, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Kazan Medical Instruments Plant Joint Stock CompanKAZAN Tatarstan, RussiaManufacturer0000api.fda.gov
KB Components Dallas, Inc.Arlington, TX, United StatesManufacturer0000api.fda.gov
KLS Martin Se & Co. KGFridingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS Martin Malaysia Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer0000api.fda.gov
Kreidler Medizintechnik GmbHWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
L&K Biomed Co.,ltd.Yongin-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer0000api.fda.gov
Madina Surgical WorksSialkot Punjab, PakistanManufacturer0000api.fda.gov
Maire-DidierChaumont Haute-Marne, FranceContract manufacturer0000api.fda.gov
Marida, Marianne Daniels Chir. Instr.SOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Maryam TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Max Hauser Suddeutsche Chirurgiemechanik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Med Michigan Holdings LLCLake Odessa, MI, United StatesManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medical Specialties Inc.Durham, NC, United StatesContract manufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Medisporex (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Meister Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Metro MedicalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Millennium Surgical CorpSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Naqeebe EnterprisesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Oculo Plastik, Inc.MONTREAL Quebec, CanadaManufacturer0000api.fda.gov
Onyx Industries, Inc.Gardena, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
OsteomedAddison, TX, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Oury-Guye & FilsNOGENT Haute-Marne, FranceContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Princeton Medical Group, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
Precision Medical Devices IncNew Brunswick, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Reda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ridge & Crest CompanyMonterey Park, CA, United StatesSpecification developer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Rudischhauser Surgical Instruments Manufacturing GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Rudolf Medical GMBH + Co. KGFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
S & T AGNEUHAUSEN Schaffhausen, SwitzerlandManufacturer0000api.fda.gov
Scanlan International, Inc.Saint Paul, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
SIGN Fracture Care InternationalRichland, WA, United StatesManufacturer0000api.fda.gov
Signor Seven InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Simon SASBayeux Calvados, FranceContract manufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Sitec (pvt.) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Smi Medical Instruments GMBH & Co.kgNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Solatch SonsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Sterramed IncWeehawken, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Stille ABTorshalla Sodermanland, SwedenManufacturer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SUBAN Instruments Hungary Co.DEBRECEN Hajdu-Bihar, HungaryContract manufacturer0000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Surgi Tech Instruments MFG. Co.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Surgical Instruments Belgium SAGEMBLOUX Namur, BelgiumContract manufacturer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurjexSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Surtex Instruments LtdLondon Surrey, United KingdomManufacturer0000api.fda.gov
Swengg CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Stehle MedizintechnikRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Tonglu Wanhe Medical Instrument Co., Ltd.Hangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ulrich GMBH & Co. KGULM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ultra Surgical (pvt.) LtdSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Vycor Medical IncBoca Raton, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Washington Surgical InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
WILDmedical GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaManufacturer0000api.fda.gov

Updated May 2, 2016. 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.