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Data / Medical devices / Pliers, Surgical

Pliers, Surgical (HTC): 196 FDA-registered makers in 21 countries

196 establishments in 21 countries are registered with the FDA to make Pliers, Surgical (product code HTC, Class 1, 21 CFR 878.4800). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on July 2, 1987, and lists 4 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
HTC
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States64
Pakistan54
Germany35
China9
Switzerland7
France5
India3
Poland2
Mexico2
Italy2
Finland2
Brazil2
Canada1
Ireland1
Netherlands1
Australia1
Malaysia1
United Arab Emirates1
Latvia1
Hungary1
United Kingdom1

Makers of Pliers, Surgical

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
Accuratus AGBern, SwitzerlandManufacturer0000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Acme EnterprisesSialkot 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, PakistanManufacturer0000api.fda.gov
Arc PrecisionIsanti, MN, United StatesContract manufacturer0000api.fda.gov
Armatech InternationalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer0000api.fda.gov
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avilign MedicalSialkot Punjab, PakistanContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Able Medical DevicesMarquette, MI, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Beijing Fule Science & Technology Development Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Biomet FranceValence Drome, FranceManufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov
Bodycad Laboratories, Inc.Quebec, CanadaComplaint file establishment, Manufacturer0000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Circumfix Solutions, IncCollierville, TN, United StatesSpecification developer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Commic SurgicoSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
Darleys Surgical Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Elmed Instruments (pvt). Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Eltek Instruments (pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Erchinger AGTUTTLINGEN Baden-Wurttemberg, GermanyContract 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
Flospine LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
Fmi Medisch BVSchiedam Zuid-Holland, NetherlandsContract manufacturer0000api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka KomandytowaRUDNIKI K/CZESTOCHOWY Slaskie, PolandManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Fujian Hui'an Hecheng Household Products Co., LtdQuanzhou Fujian, ChinaManufacturer0000api.fda.gov
G. Hipp & Sohn GMBHNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
G21 S.R.I.San Possidonio Modena, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Geister Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer0000api.fda.gov
Ghousia Amanat SurgicalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Gsource, LLC.Emerson, NJ, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
H & H Co.Hayden, ID, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Tonglu Shikonghou Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Harf IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hazel EnterprisesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN 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
Haven ManufacturingOssian, IN, United StatesContract manufacturer0000api.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
In'tech Medical SASRANG DU FLIERS Pas-de-Calais, FranceContract manufacturer, Exporter to the US0000api.fda.gov
Infirmary Medical SuppliesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer, Specification developer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Innomed, Inc.Savannah, GA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Instrumental Machine & Development, Inc.Warsaw, IN, United StatesContract manufacturer0000api.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 GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.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
Jay-MedSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Kapp Surgical GMBHDUERBHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Hammacher GMBHSOLINGEN North Rhine-Westphalia, GermanyManufacturer0000api.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
Kalitec Direct LLC DBA Kalitec MedicalSarasota, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Kohler Medizintechnik GmbHSTOCKACH Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Limacorporate S.p.A.Villanova di San Daniele Udine, ItalyManufacturer0000api.fda.gov
Madina Surgical WorksSialkot Punjab, PakistanManufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maryam TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Mclean Medical & ScientificSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
Mectalent Ltd.Oulu Kainuu, FinlandContract manufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
MEDITEC SOURCE GmbH & Co. KGTuttlingen-Nendingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Miraclus Orthotech Private LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Manogg Medical KGHohenfels Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Neoortho Produtos Ortopedicos S/ACuritiba Parana, BrazilManufacturer0000api.fda.gov
Newclip Technics SASHAUTE GOULAINE Loire-Atlantique, FranceManufacturer0000api.fda.gov
Nextcon InternationalSialkot Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesSpecification developer0000api.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
Pfau Medizinische Instrumente GMBHWANFRIED Hesse, GermanyContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer0000api.fda.gov
Power Dental USA, Inc.McHenry, IL, United StatesManufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Precision Medical Manufacturing LLCWheeling, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
S & T AGNEUHAUSEN Schaffhausen, SwitzerlandManufacturer0000api.fda.gov
S. S. White Technologies India Pvt. Ltd.Surendranagar Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
S.G. ManufacturersSialkot Punjab, PakistanManufacturer0000api.fda.gov
S.S. White Technologies, Inc. / Dba Shukla MedicalSt Petersburg, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Sabokay IndustriesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Sabri IndustriesSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Reach Medical Instrument Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Sitec (pvt.) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SMT Schilling Metalltechnik GMBHMUHLHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
Spinevision SASAntony Hauts-de-Seine, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Stone Instruments Co.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Storz Am Mark GMBHEMMINGEN-LIPTINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SUBAN Instruments Hungary Co.DEBRECEN Hajdu-Bihar, HungaryContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurgikareSIALKOT Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
Surtex Instruments LtdLondon Surrey, United KingdomManufacturer0000api.fda.gov
Swantia Medical Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0010api.fda.gov
T.A. Walthem & CompanySialkot 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
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.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
Visionare LLCFort Myers, FL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Volgo Care International (private) LimitedSialkot Punjab, PakistanContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Washington Surgical InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Zain's Medical ImageSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov
medi-plus Instrumente GmbHTUTTLINGEN-NENDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated July 2, 1987. 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.