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Data / Medical devices / Introducer, Catheter

Introducer, Catheter (DYB): 182 FDA-registered makers in 19 countries

182 establishments in 19 countries are registered with the FDA to make Introducer, Catheter (product code DYB, Class 2, 21 CFR 870.1340). 126 of them have a 510(k) clearance or PMA approval on file and 29 have a recall event. The FDA has issued 707 510(k) clearances under this code, the latest on October 15, 2026, and lists 159 recall events (15 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
DYB
Device class
2
Regulation
870.1340
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States113
Mexico16
China11
Ireland9
Costa Rica7
Canada5
Germany4
Czechia3
Japan2
Dominican Republic2
India2
Egypt1
Israel1
Belgium1
Switzerland1
France1
Malaysia1
South Korea1
Singapore1

Makers of Introducer, Catheter

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
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer31December 13, 2024030api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler, Specification developer19April 25, 20250152api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer18March 25, 20240141api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler14July 5, 2016000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler13December 15, 2025030api.fda.gov
Terumo Medical Corp.Elkton, MD, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler13January 6, 2020071api.fda.gov
Oscor Inc.Palm Harbor, FL, United StatesComplaint file establishment, Contract manufacturer, Manufacturer12June 3, 2021061api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer, Manufacturer for export11December 13, 2024000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler11January 4, 2013000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer10January 4, 20130170api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer10November 4, 2016010api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer10February 12, 2016010api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer10December 17, 2023021api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer9March 20, 2025000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer9April 24, 2023030api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer8July 25, 2019000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer, Reprocessor, Specification developer8December 13, 2024060api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer, Repackager or relabeler7January 4, 2013000api.fda.gov
Boston Scientific CorporationMississauga Ontario, CanadaManufacturer, Specification developer7December 20, 2023000api.fda.gov
Contract Medical International GmbHDRESDEN Saxony, GermanyManufacturer7March 16, 2025010api.fda.gov
Greatbatch MedicalMinneapolis, MN, United StatesComplaint file establishment, Manufacturer, Specification developer6July 26, 20180100api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer, Specification developer5March 1, 2023000api.fda.gov
Abbott Medical Costa Rica Ltda.El Coyol Alajuela, Costa RicaManufacturer5December 13, 2024000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaManufacturer5October 31, 2001000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer5July 15, 2003000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer5June 5, 2026000api.fda.gov
Edwards Lifesciences LLCIrvine, CA, United StatesManufacturer, Specification developer5April 17, 2026010api.fda.gov
Galt Medical Corp.Garland, TX, United StatesComplaint file establishment, Manufacturer5August 21, 2014040api.fda.gov
Abiomed, Inc.Danvers, MA, United StatesComplaint file establishment, Specification developer4January 19, 2023042api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Repackager or relabeler4October 31, 2007000api.fda.gov
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer4July 25, 2017020api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer4March 6, 2014000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer4July 5, 2016000api.fda.gov
Biocardia, Inc.Sunnyvale, CA, United StatesManufacturer3August 23, 2024020api.fda.gov
CIRCA Scientific, Inc.Englewood, CO, United StatesSpecification developer3April 24, 2025000api.fda.gov
Cordis de Mexico, SA de CVJUAREZ Chihuahua, MexicoManufacturer3May 10, 2000000api.fda.gov
Edwards Lifesciences LLCDraper, UT, United StatesManufacturer3April 17, 2026000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Specification developer3September 24, 2025000api.fda.gov
Theragenics Costa Rica LimitadaEl Coyol Alajuela, Costa RicaManufacturer3April 12, 2013000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer3July 5, 2016000api.fda.gov
W. L. Gore & Associates, Inc.Phoenix, AZ, United StatesComplaint file establishment, Specification developer3July 21, 2016010api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer2July 19, 2017010api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer2July 19, 2017000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer2June 20, 2003010api.fda.gov
Beijing Demax Medical Technology Co., Ltd.Beijing, ChinaManufacturer2August 22, 2024000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer2March 20, 2025021api.fda.gov
Boston Scientific CorporationCartago, Costa RicaManufacturer2May 9, 2022000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2May 20, 2019000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer2May 9, 2022000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer2March 20, 2025000api.fda.gov
Cardiocycle Medical(suzhou) Co.,ltd.Suzhou Jiangsu, ChinaComplaint file establishment, Manufacturer2April 23, 2026000api.fda.gov
Clearstream Technologies Ltd.Wexford, IrelandManufacturer2September 23, 2021000api.fda.gov
Cardinal Health Mexico 244 S de RL de CVCiudad Juarez Chihuahua, MexicoContract manufacturer, Manufacturer2October 11, 1996000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer2October 7, 1987000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesContract manufacturer, Manufacturer2June 20, 2003000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer2July 25, 2019000api.fda.gov
Insitu Technologies, Inc.Saint Paul, MN, United StatesSpecification developer2February 9, 2005000api.fda.gov
Inari Medical, Inc.Irvine, CA, United StatesManufacturer2December 12, 2023000api.fda.gov
Lepu Medical Technology (beijing) Co., LtdBeijing, ChinaManufacturer2March 2, 2018000api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer2October 7, 1987000api.fda.gov
Medtronic VascularSanta Rosa, CA, United StatesSpecification developer2December 20, 2017000api.fda.gov
Nova Vascular LLCNew York, NY, United StatesSpecification developer2October 21, 2025000api.fda.gov
RLS Interventional Inc. DBA InradGrand Rapids, MI, United StatesManufacturer2November 16, 1981000api.fda.gov
Shanghai Microport Ep Medtech Co., Ltd.Shanghai, ChinaManufacturer2March 23, 2022000api.fda.gov
Synaptic Medical CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer2February 16, 2024000api.fda.gov
Togo Medikit Co., Ltd.HYUGA CITY Miyazaki, JapanComplaint file establishment, Manufacturer2September 27, 2012000api.fda.gov
Teleflex LLCBrooklyn Park, MN, United StatesManufacturer2May 9, 2018000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Repackager or relabeler, Specification developer2May 9, 2018000api.fda.gov
Vizaramed, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer2March 26, 2026000api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer1July 27, 2021000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Specification developer1April 13, 1994000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer1April 13, 1994000api.fda.gov
Ameco Medical Industries10TH OF RAMADAN CITY Ash Sharqiyah, EgyptManufacturer1August 15, 2013000api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer1September 18, 2008000api.fda.gov
AtriCure, Inc.Pleasanton, CA, United StatesSpecification developer1February 13, 2024000api.fda.gov
B. Braun Dominican Republic Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer, Repackager or relabeler1November 30, 1989000api.fda.gov
Becton Dickinson Infusion Therapy Systems Inc.Sandy, UT, United StatesManufacturer, Specification developer1June 12, 2002010api.fda.gov
Becton Dickinson Medical Devices Co., Ltd. SuzhouSuzhou Jiangsu, ChinaManufacturer1May 31, 2022000api.fda.gov
CARDIOVIA Ltd.Nazareth Northern, IsraelManufacturer1March 20, 2025000api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer1June 12, 2002000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer1August 9, 1989000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer1August 9, 1989000api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer1April 17, 2014000api.fda.gov
Cultiv8 1, LLCMinneapolis, MN, United StatesComplaint file establishment, Specification developer1January 22, 2026000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1October 6, 1992000api.fda.gov
Cardinal Health Costa Rica, S.A.-- Alajuela, Costa RicaContract manufacturer, Manufacturer1October 6, 1992000api.fda.gov
Creagh Medical Ltd.Co. Galway Galway(County), IrelandManufacturer1April 18, 2019000api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer1April 27, 2022000api.fda.gov
Curatia Medical LimitedSuzhou Jiangsu, ChinaManufacturer1April 27, 2022000api.fda.gov
DimequipFrameries Hainaut, BelgiumManufacturer1November 27, 1981000api.fda.gov
Eosolutions, Corp.Miramar, FL, United StatesComplaint file establishment, Specification developer1September 27, 2023000api.fda.gov
Edwards Lifesciences Ireland LimitedLimerick Munster, IrelandManufacturer1March 9, 2020000api.fda.gov
Endologix LLCSanta Rosa, CA, United StatesComplaint file establishment, Specification developer1February 9, 2012000api.fda.gov
Endologix LLCIrvine, CA, United StatesManufacturer1February 9, 2012000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer1February 24, 2010000api.fda.gov
Freudenberg Medical, LLCJeffersonville, IN, United StatesComplaint file establishment, Contract manufacturer, Manufacturer1May 30, 2019010api.fda.gov
Hartman Medical Group,LLCBirmingham, AL, United StatesComplaint file establishment, Specification developer1July 6, 2026000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1February 9, 2012000api.fda.gov
Inquis Medical, Inc.Menlo Park, CA, United StatesManufacturer1April 13, 2026000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer1September 19, 2007000api.fda.gov
Medtronic IrelandGALWAY Galway(County), IrelandSpecification developer1August 7, 2015011api.fda.gov
Medtronic CryoCath LPPointe-Claire Quebec, CanadaManufacturer1February 2, 2017000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer1October 20, 2017000api.fda.gov
Oscor Caribe LLCSANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer, Contract sterilizer, Manufacturer1September 22, 2015000api.fda.gov
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1February 6, 2012000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer1November 20, 2024000api.fda.gov
Pressure Products Medical Device Manufacturing LLCMorton, PA, United StatesManufacturer1October 26, 2018000api.fda.gov
Protaryx Medical, LLCBaltimore, MD, United StatesManufacturer1April 10, 2026000api.fda.gov
Pulnovo Medical (wuxi) Co., Ltd.Wuxi Jiangsu, ChinaManufacturer1November 8, 2024000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer1November 20, 2024000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer1November 20, 2024000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer1November 20, 2024000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesManufacturer, Repackager or relabeler1November 9, 1993000api.fda.gov
Respicardia, Inc.Minnetonka, MN, United StatesComplaint file establishment, Specification developer1April 6, 2026000api.fda.gov
South53San Juan Capistrano, CA, United StatesManufacturer1September 29, 2025000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesManufacturer1December 8, 2008000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesSpecification developer1April 18, 2019000api.fda.gov
Synaptic Medical LimitedBeijing, ChinaManufacturer1December 4, 2015000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer1January 24, 2013000api.fda.gov
Stryker Sustainability Solutions PhoenixPhoenix, AZ, United StatesReprocessor1January 24, 2013000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler1August 9, 1989000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer, Manufacturer1March 24, 2000000api.fda.gov
Vascutech Medical, LLCOaks, PA, United StatesManufacturer1February 9, 2026000api.fda.gov
VYGON Germany GmbHAACHEN North Rhine-Westphalia, GermanyManufacturer1September 28, 2001000api.fda.gov
Vygon S AECOUEN 95440 Val-d'Oise, FranceManufacturer1November 27, 1981000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer1November 8, 1991000api.fda.gov
Advanced Lifesciences Pvt. Ltd.New Delhi, IndiaExporter to the US, Manufacturer0000api.fda.gov
Agile MVMontreal Quebec, CanadaContract manufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Abbott Medical Mexico, S. de R.L. de C.V.Santa Rosa Jauregui Queretaro, MexicoManufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
B. Braun Medical Industries Sdn. Bhd.PENANG Pulau Pinang, MalaysiaContract manufacturer, Contract sterilizer0000api.fda.gov
B. Braun Melsungen AGMELSUNGEN Hesse, GermanySpecification developer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Contract sterilizer0040api.fda.gov
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.NOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
BiomericsSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Cardiofocus, Inc.Marlborough, MA, United StatesManufacturer, Specification developer0000api.fda.gov
Carefusion 2200, Inc.Mannford, OK, United StatesContract manufacturer0000api.fda.gov
Contract Medical International, Spol. S R.O.Hradec Kralove, CzechiaContract manufacturer0000api.fda.gov
CPE1, LLC DBA Greatbatch MedicalSouthwest Ranches, FL, United StatesContract manufacturer0000api.fda.gov
Creganna Medical Ireland LimitedBALLYBRIT Galway(County), IrelandContract manufacturer0020api.fda.gov
Custom Tube Manufacturing LLCYangju-si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaManufacturer0000api.fda.gov
Cirtec MedicalSanta Clara, CA, United StatesContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
EPIC MedTec OEM Ireland LimitedANNACOTTY Limerick(County), IrelandContract manufacturer0000api.fda.gov
EPIC MedTec OEM LLCJaffrey, NH, United StatesContract manufacturer0000api.fda.gov
Freudenberg Medical Ireland LimitedLeitrim, IrelandContract manufacturer0000api.fda.gov
Goodwill Commercial ServicesIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Greatbatch Medical, S. de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Hart Enterprises, Inc.Sparta, MI, United StatesContract manufacturer0000api.fda.gov
Harsoria Healthcare Pvt. Ltd. (Unit-2)Baddi Himachal Pradesh, IndiaContract manufacturer, Contract sterilizer0000api.fda.gov
Heraeus Medical Components, SRLGuadalupe Cartago, Costa RicaContract manufacturer0000api.fda.gov
Innovative Health, LLC.Scottsdale, AZ, United StatesReprocessor0000api.fda.gov
Irvine Biomedical. Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Isomedix Operations Inc.Northborough, MA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Isomedix Operations Inc.S Plainfield, NJ, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
KARDIUM Inc.Burnaby British Columbia, CanadaManufacturer0000api.fda.gov
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer0000api.fda.gov
LightningcathBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Mehow Innovative (huizhou) Ltd.Huizhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0090api.fda.gov
NeedleTech Products, Inc.N Attleboro, MA, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
PDV MedTechMorgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Quasar Medical (singapore) Pte. Ltd.Singapore North West, SingaporeContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Sterilization Services Of VirginiaRichmond, VA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Switchback MedicalBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Shanghai INT Medical Instruments Co., Ltd.Shanghai, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tianjin Demax Medical Technology Co., Ltd.Tianjin, ChinaContract manufacturer0000api.fda.gov
Terumo BCT STERILIZATION SERVICES, Inc.Lakewood, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Theragenics Costa Rica LimitadaEl Coyol, Alajuela, Costa RicaManufacturer0000api.fda.gov

Updated October 15, 2026. 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.