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Data / Medical devices / Forceps, Ophthalmic

Forceps, Ophthalmic (HNR): 193 FDA-registered makers in 28 countries

193 establishments in 28 countries are registered with the FDA to make Forceps, Ophthalmic (product code HNR, Class 1, 21 CFR 886.4350). 0 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 44 510(k) clearances under this code, the latest on November 1, 2002, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HNR
Device class
1
Regulation
886.4350
Medical specialty
Ophthalmic

Makers by country

CountryMakers
Pakistan47
Germany42
United States40
China12
India12
United Kingdom8
Switzerland4
France3
Malaysia2
Mexico2
Taiwan2
Japan2
Netherlands2
Poland1
Italy1
Slovakia1
South Africa1
Mauritius1
Belgium1
Honduras1
Australia1
Canada1
United Arab Emirates1
Latvia1
Turkey1
Hungary1
Hong Kong1
Russia1

Makers of Forceps, Ophthalmic

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
66 Vision Tech Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
A1 Medical GMBHTuttlingen Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Acme Commercial Ways Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Addition Technology, Inc.Lombard, IL, United StatesManufacturer0000api.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
Akriti Ophthalmic Private LimitedHyderabad Telangana, IndiaManufacturer0000api.fda.gov
Aktive SRLRome Lazio, ItalyManufacturer0000api.fda.gov
Alcon Grieshaber AGNeuhausen Schaffhausen, SwitzerlandSpecification developer0000api.fda.gov
Alcon Grieshaber AGSchaffhausen, SwitzerlandManufacturer0000api.fda.gov
AlframedSialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Altomed Ltd.Boldon Colliery South Tyneside, United KingdomManufacturer0000api.fda.gov
Appasamy Associates Private Limited ( Thruvandar Koil)Mannadipet Commune Puducherry, IndiaManufacturer0000api.fda.gov
Appasamy Associates Private Limited (MN Kuppam)Villupuram District Tamil Nadu, IndiaManufacturer0000api.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
Aurora Surgical, LLCSt Petersburg, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer0000api.fda.gov
Alcon Research, LLCFort Worth, TX, United StatesSpecification developer0010api.fda.gov
Amann Medical GmbH & Co. KGEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
AsuznaSialkot Punjab, PakistanManufacturer0000api.fda.gov
B&H Surgical InstrumentSialkot Punjab, PakistanManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Bear-Ent, LLCMalvern, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bis MastermedKosice Kosicky, SlovakiaManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bruder Healthcare CompanyFairfield, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bausch & Lomb IncorporatedManchester, MO, United StatesManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedEppelheim Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesManufacturer0010api.fda.gov
Beaver-Visitec International, Inc.Ciudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Beaver-Visitec International, LtdBIDFORD-ON-AVON Warwickshire, United KingdomManufacturer0000api.fda.gov
Belle Healthcare Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Berger Surgical Medical Products GmbHNeuhausen ob Eck Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Bioteque Corporation I-Lan Factory IISu-Ao Cheng Yilan, TaiwanContract manufacturer, Contract sterilizer0000api.fda.gov
BlephEx, LLCBrentwood, TN, United StatesManufacturer0000api.fda.gov
Blink Medical LTDSolihull, United KingdomManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Carl Teufel GMBH & Co. KGLIPTINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Charmant, Inc.Sabae-City, Fukui-Pref., JapanManufacturer0000api.fda.gov
Choose Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Coba Biomedical Pty (ltd)Bloemfontein Free State, South AfricaContract manufacturer0000api.fda.gov
Comfort Surgical InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Crown Surgical Corp.Sialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.ZUIDLAND Zuid-Holland, NetherlandsComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Daddy D ProSialkot Punjab, PakistanManufacturer0000api.fda.gov
Daud Jee MFG CoSialkot Punjab, PakistanManufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
DR. Frigz International (pvt) Ltd.SIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Duckworth & Kent, Ltd.BALDOCK Hertfordshire, United KingdomManufacturer0000api.fda.gov
Dufner Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dausch Medizintechnik GmbHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Denzel Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Elmed Instruments (pvt). Ltd.SIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Emerald InstrumentsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Empire Surgical Instruments CompanySialkot Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Epsilon Eye Care Pvt., Ltd.MUMBAI Maharashtra, IndiaManufacturer0000api.fda.gov
Europlaz Technologies Ltd.Southminster Essex, United KingdomContract manufacturer0000api.fda.gov
Eye Technology Ltd.RAYLEIGH Essex, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
F.A. Najmmy IndustriesSialkot Punjab, PakistanContract manufacturer0000api.fda.gov
Fci SASBESANCON Doubs, FranceForeign private label distributor, Manufacturer0000api.fda.gov
Fci SudMAPOU LECLEZIO GOODLANDS Riviere du Rempart, MauritiusForeign private label distributor, 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
Frank MuellerMoessingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Fischer Surgical Inc.Imperial, MO, United StatesManufacturer0000api.fda.gov
G.A. Surgical (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garish ApparelsWazirabad Punjab, PakistanManufacturer0000api.fda.gov
Georg Alber GMBH & Co. KGRENQUISHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Geuder AGHEIDELBERG Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Guenter Bissinger Medizintechnik GMBHTENINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Hans Freudenstein Chir-MikroinstrumentePASSAU Bavaria, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Hasa OptixBrussels Brussels-Capital Region, BelgiumManufacturer0000api.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
Hico Surgical Private Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro Instruments (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hilbro International (pvt) LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Huaian Frimen Co., LtdHuaian Jiangsu, ChinaManufacturer0000api.fda.gov
Huaian Tisurg Medical Instruments Co., Ltd.Huaian City Jiangsu, ChinaManufacturer0000api.fda.gov
Huaian Wolfram Surgical InstrumentsHuaian Jiangsu, ChinaManufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Hubei Lanbin Medical Group Co., Ltd.Xiaogan City Hubei, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Iscon Surgicals, Ltd.JODHPUR Rajasthan, IndiaManufacturer0000api.fda.gov
Instrumed GmbH dba Avalign German Specialty InstrumentsTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, 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
Jay-MedSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Kalson SurgicalSialkot Punjab, PakistanManufacturer0000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer0010api.fda.gov
Katena Products, Inc.Fenton, MO, United StatesContract manufacturer, 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
Kdans Surgical Private LimitedGANDHINAGAR Gujarat, IndiaContract manufacturer0000api.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
Laparomed Private LimitedMumbai Maharashtra, IndiaManufacturer0000api.fda.gov
M/S Tarun EnterprisesPrayagraj, Uttar Pradesh, IndiaManufacturer0000api.fda.gov
MANFRED HILZINGER GmbH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Mani, Inc. (head Office)UTSUNOMIYA Tochigi, JapanManufacturer0000api.fda.gov
Manufactures D'outils Dumont S.A.MONTIGNEZ Jura, SwitzerlandManufacturer0000api.fda.gov
Maryam TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mattes Instrumente GMBHTuttlingen-Nendingen Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler0000api.fda.gov
Mazado Inc.Toronto Ontario, CanadaSpecification developer0000api.fda.gov
Med Invent Devices Pvt. Ltd.KOLKATA West Bengal, IndiaSpecification developer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medone Surgical, Inc.Sarasota, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Mian Shahid Corp.MUZAFFAR PUR, SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Microqore Medical GMBHAach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Microsurgical Technology, Inc.Redmond, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Miqraz Surgical IndustriesSialkot Punjab, PakistanManufacturer0000api.fda.gov
Moria S.A.MASSY Hauts-de-Seine, FranceSpecification developer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Malosa Medical Instruments (Changshu) LimitedChangshu Jiangsu, ChinaContract manufacturer0000api.fda.gov
Midwest Medical MfgOakland, AR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Moria S.ABourbon l'Archambault Allier, FranceExporter to the US, Manufacturer0000api.fda.gov
Nadir & Co.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Network Medical Products, Ltd.Ripon North Yorkshire, United KingdomManufacturer0000api.fda.gov
Optico LtdLETCHWORTH Hertfordshire, United KingdomContract manufacturer0000api.fda.gov
Optego Vision USA, Inc.Tucson, AZ, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Pilotis Tech LLCBrookhaven, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
PMS GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Pro-Med Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Perfect Ophthalmic Instruments FZEDubai Dubayy, United Arab EmiratesManufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
QTD PlasticsMeadville, PA, United StatesContract manufacturer0000api.fda.gov
Quality Concept (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
RC Consolidated Services, IncRancho Cucamonga, CA, United StatesSpecification developer0000api.fda.gov
Regine SwitzerlandMORBIO, INFERIORE Ticino, SwitzerlandManufacturer0000api.fda.gov
RUMEX Baltics SIARiga, LatviaManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Scharf Tools Ihracat Ithalat Limited SirketiFatih Istanbul, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Schmid Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SGS Export Intl.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Shern Yeong Precise Optical Co., Ltd.Dongshan Township, Yilan County, TaiwanContract manufacturer0000api.fda.gov
Sihong Ophsurin Co., LtdSuqian Jiangsu, ChinaManufacturer0000api.fda.gov
Sinntech Medical (private) LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Spartech Instruments & Co.Sialkot, Punjab, PakistanManufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
Sprenger GMBHFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Stephens Instruments, IncLexington, KY, United StatesManufacturer, Repackager or relabeler, Reprocessor0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
SUBAN Instruments Germany GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SUBAN Instruments Hungary Co.DEBRECEN Hajdu-Bihar, HungaryContract manufacturer0000api.fda.gov
Suqian Zhengtong Medical Instruments Co. LtdChina, Hong KongContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
SurgiscapeSialkot Punjab, PakistanManufacturer0000api.fda.gov
SurjexSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Synergetics, Inc.O Fallon, MO, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Shamsi SurgicalSialkot Punjab, PakistanContract manufacturer0000api.fda.gov
Strub Medical GmbH & Co. KGNEUHAUSEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
T.A. Walthem & CompanySialkot Punjab, PakistanManufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tecno Instruments (pvt.) Ltd.SIALKOT Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Tekno Medical Optik-Chirurgie GMBHTUTTLINGEN-Nendingen Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Titan SurgicalKAZAN Tatarstan, RussiaRepackager or relabeler, Specification developer0000api.fda.gov
Total Titanium, Inc.Red Bud, IL, United StatesContract manufacturer, Remanufacturer0000api.fda.gov
Towne Brothers (pvt.), Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.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
Visuscience Meditech Co., Ltd.WUXI Jiangsu, ChinaSpecification developer0000api.fda.gov
Vitreq BVVierpolders Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Volk Optical Inc.Mentor, OH, United StatesManufacturer0000api.fda.gov
Vortex Surgical, Inc.Saint Charles, MO, United StatesManufacturer0020api.fda.gov
WILDmedical GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Win Wings Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Xinhua Surgical Instrument Co. Ltd.ZIBO Shandong, ChinaManufacturer0000api.fda.gov
Zepf Medical Instruments GMBHSEITINGEN-OBERFLACHT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated November 1, 2002. 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.