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Data / Medical devices / Catheter, Percutaneous

Catheter, Percutaneous (DQY): 188 FDA-registered makers in 20 countries

188 establishments in 20 countries are registered with the FDA to make Catheter, Percutaneous (product code DQY, Class 2, 21 CFR 870.1250). 127 of them have a 510(k) clearance or PMA approval on file and 27 have a recall event. The FDA has issued 896 510(k) clearances under this code, the latest on September 18, 2026, and lists 127 recall events (14 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
DQY
Device class
2
Regulation
870.1250
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States127
Ireland10
Mexico10
China10
Costa Rica7
Japan5
Czechia2
Netherlands2
Canada2
France2
Singapore2
Germany1
Switzerland1
Thailand1
South Africa1
Vietnam1
Israel1
Mauritius1
Greece1
Philippines1

Makers of Catheter, Percutaneous

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 MedicalRoseville, MN, United StatesManufacturer20July 2, 2026000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer19August 18, 2022000api.fda.gov
Abbott MedicalPlymouth, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export17July 2, 2026000api.fda.gov
Abbott MedicalSaint Paul, MN, United StatesManufacturer, Specification developer17July 2, 2026000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Specification developer17February 1, 2024020api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Repackager or relabeler, Specification developer17January 10, 2023030api.fda.gov
Medtronic IrelandGALWAY Galway(County), IrelandManufacturer15October 29, 2025000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer15December 15, 2019080api.fda.gov
Abbott MedicalSylmar, CA, United StatesManufacturer, Manufacturer for export, Specification developer14June 2, 2023010api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer14February 1, 2024000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer14December 12, 2019071api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer14August 22, 2023000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Manufacturer for export, Specification developer13February 1, 20240151api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer13February 1, 2024000api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer, Manufacturer for export12June 30, 2022000api.fda.gov
Asahi Intecc Co., Ltd.SETO Aichi, JapanManufacturer, Specification developer12June 25, 2024000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer12June 28, 2024050api.fda.gov
Medtronic VascularDanvers, MA, United StatesManufacturer, Manufacturer for export, Specification developer12August 22, 2023051api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler11June 23, 2017000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer11June 23, 20170160api.fda.gov
Reflow Medical, IncSan Clemente, CA, United StatesManufacturer11August 22, 2025011api.fda.gov
Reflow MedicalLake Forest, CA, United StatesContract manufacturer, Manufacturer11February 8, 2024000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Specification developer11August 18, 2022052api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export10April 29, 2025000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer10June 11, 2020000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer, Specification developer10September 22, 2016030api.fda.gov
Biotronik Se & Co. KGBerlin, GermanyManufacturer9September 12, 2024000api.fda.gov
Cardinal Health Mexico 244 S de RL de CVCiudad Juarez Chihuahua, MexicoContract manufacturer, Manufacturer9January 14, 2015000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer9December 19, 2025050api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer9May 28, 2024000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer9June 11, 2020030api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer9June 11, 2020000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer9June 11, 2020000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler9June 23, 2017000api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer, Repackager or relabeler8June 23, 2017000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer8May 4, 2022070api.fda.gov
Stryker NeurovascularCork Munster, IrelandManufacturer8March 13, 2019000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesComplaint file establishment, Manufacturer7July 29, 2026000api.fda.gov
IMDS Operations B.V.Roden Groningen, NetherlandsManufacturer7August 14, 2026000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer7November 8, 2019000api.fda.gov
Numed Canada, Inc.CORNWALL Ontario, CanadaManufacturer7August 31, 2012000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaManufacturer6June 23, 2017000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer6January 6, 2017000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer6November 8, 2019000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer6August 31, 2012000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer, Manufacturer6August 18, 2022000api.fda.gov
Cordis de Mexico SA de CVCiudad Juarez, Chihuahua Mexico, MexicoManufacturer5November 8, 2019000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Repackager or relabeler, Specification developer5January 15, 2025020api.fda.gov
Teleflex LLCBrooklyn Park, MN, United StatesManufacturer5April 30, 2021000api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanContract manufacturer, Manufacturer4March 3, 2021000api.fda.gov
OrbusNeich Medical (Shenzhen) Co., Ltd.SHENZHEN Guangdong, ChinaComplaint file establishment, Manufacturer4April 10, 2026000api.fda.gov
Alembic LLCMountain View, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3May 1, 2025000api.fda.gov
Pendracare International B.V.Leek Groningen, NetherlandsManufacturer3June 29, 2025000api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer3February 27, 2015020api.fda.gov
Stryker NeurovascularSalt Lake City, UT, United StatesManufacturer3January 27, 2016000api.fda.gov
W. L. Gore & Associates, Inc.Phoenix, AZ, United StatesManufacturer3June 2, 2025000api.fda.gov
Abbott VascularMenlo Park, CA, United StatesManufacturer, Manufacturer for export2December 31, 2024000api.fda.gov
Biocardia, Inc.Sunnyvale, CA, United StatesManufacturer2January 7, 2020000api.fda.gov
Boston Scientific CorporationCartago, Costa RicaManufacturer2February 1, 2024000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2August 8, 2023010api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer2February 1, 2024000api.fda.gov
Cardiovascular Systems IncorporatedSaint Paul, MN, United StatesComplaint file establishment, Specification developer2August 26, 2021000api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer2December 14, 2018000api.fda.gov
Curatia Medical LimitedSuzhou Jiangsu, ChinaManufacturer2December 14, 2018000api.fda.gov
Okami Medical Inc.Aliso Viejo, CA, United StatesManufacturer2December 20, 2024000api.fda.gov
Q'apel Medical, Inc.Fremont, CA, United StatesManufacturer2October 31, 2019000api.fda.gov
Qxmedical, LLCSaint Paul, MN, United StatesContract manufacturer, Manufacturer, Manufacturer for export2November 2, 2016000api.fda.gov
Route 92 Medical, Head QuartersSan Mateo, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2January 13, 2020011api.fda.gov
Route 92 Medical, West JordanW Jordan, UT, United StatesManufacturer, Repackager or relabeler2January 13, 2020000api.fda.gov
Seigla Medical, Inc.Buffalo, MN, United StatesSpecification developer2April 4, 2025000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2October 14, 2022000api.fda.gov
W. L. Gore & Associates, IncFlagstaff, AZ, United StatesManufacturer2October 5, 2018000api.fda.gov
Wallaby MedicalLaguna Hills, CA, United StatesSpecification developer2October 13, 2023000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer2October 21, 2021000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer1August 15, 2012000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, Manufacturer1February 15, 1991010api.fda.gov
Asahi Intecc (thailand) Co., Ltd.Amphur Muang Pathumthani Pathum Thani, ThailandContract manufacturer, Specification developer1September 8, 2020000api.fda.gov
Asahi Intecc Usa, Inc.Tustin, CA, United StatesSpecification developer1November 29, 2019000api.fda.gov
Atricure, Inc.Mason, OH, United StatesComplaint file establishment, Manufacturer1February 8, 2008000api.fda.gov
Axiom Medical, Inc.Torrance, CA, United StatesManufacturer1August 1, 1984000api.fda.gov
Abbott MedicalWestfield, IN, United StatesManufacturer, Manufacturer for export1December 31, 2024000api.fda.gov
Abbott VascularEl Coyol Alajuela, Costa RicaExporter to the US, Manufacturer1August 15, 2012000api.fda.gov
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer1February 15, 1991000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesSpecification developer1August 25, 1986011api.fda.gov
AtriCure, Inc.Pleasanton, CA, United StatesSpecification developer1February 8, 2008000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer1March 11, 1981000api.fda.gov
Balosmark, IncKalamazoo, MI, United StatesSpecification developer1June 5, 2026000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer1March 21, 2019011api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Repackager or relabeler1August 12, 1987000api.fda.gov
Basis MedicalMiami, FL, United StatesSpecification developer1February 28, 2025000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer1October 2, 2003000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1March 20, 2008000api.fda.gov
Brevet Inc.Huntington Beach, CA, United StatesManufacturer1November 14, 1989000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer1August 12, 1987010api.fda.gov
Boston Scientific CorporationDorado, PR, United StatesManufacturer1April 3, 2014000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer1March 15, 2019000api.fda.gov
Cardiovascular Systems IncorporatedHouston, TX, United StatesManufacturer1December 29, 2018000api.fda.gov
Creagh Medical Ltd.Co. Galway Galway(County), IrelandComplaint file establishment, Manufacturer1January 12, 2018000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1October 2, 2003000api.fda.gov
Eosolutions, Corp.Miramar, FL, United StatesSpecification developer1July 29, 2022000api.fda.gov
Elumn8 Medical, IncCampbell, CA, United StatesManufacturer1December 19, 2024000api.fda.gov
FUJI SYSTEMS CORPORATION, Shin-Shirakawa PlantShirakawa Fukushima, JapanManufacturer1August 9, 2012000api.fda.gov
FUJI SYSTEMS CORPORATION, Shirakawa PlantNishi Shirakawa Gun Fukushima, JapanManufacturer1August 9, 2012000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler1July 7, 2021000api.fda.gov
Haolang Medical Usa CorporationClyde Hill, WA, United StatesSpecification developer1July 7, 2021000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer1July 12, 2016000api.fda.gov
HexacathRueil Malmaison Ile-de-France, FranceManufacturer1April 6, 2023000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer1September 26, 2018000api.fda.gov
Imperative Care Inc.Campbell, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1August 8, 2018000api.fda.gov
Kaneka Corporation Osaka PlantSettsu-shi Osaka, JapanManufacturer1August 3, 2015000api.fda.gov
Lifetech Scientific (shenzhen) Co,.ltdShenzhen Guangdong, ChinaManufacturer1February 14, 2011000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer, Specification developer1June 26, 1985000api.fda.gov
Marvao Medical Devices Ltd.Galway Galway(County), IrelandComplaint file establishment, Specification developer1June 2, 2022000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 10, 1984000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesManufacturer, Specification developer1December 21, 1988010api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer1July 17, 2003000api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1December 21, 1988000api.fda.gov
Medtronic VascularSanta Rosa, CA, United StatesSpecification developer1April 13, 2005020api.fda.gov
Respicardia, Inc.Minnetonka, MN, United StatesSpecification developer1October 17, 2013000api.fda.gov
Scientia VascularWest Valley City, UT, United StatesManufacturer1April 28, 2021010api.fda.gov
Shockwave Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Manufacturer1May 2, 2025000api.fda.gov
Strait Access Technologies Holdings (pty) LtdCape Town Western Cape, South AfricaManufacturer1June 25, 2025000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesSpecification developer1January 12, 2018000api.fda.gov
Surefire Medical, Inc.Westminster, CO, United StatesComplaint file establishment, Manufacturer1December 27, 2023000api.fda.gov
Terumo Medical Corp.Elkton, MD, United StatesManufacturer1July 27, 2023000api.fda.gov
Vantis Vascular, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer1September 30, 2024000api.fda.gov
W. L. Gore & Associates, Inc.Elkton, MD, United StatesManufacturer1October 5, 2018000api.fda.gov
Abbott VascularCLONMEL Tipperary, IrelandExporter to the US, Manufacturer0000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer0000api.fda.gov
Arrotek Medical LtdCo. Sligo Connaught, IrelandContract manufacturer0000api.fda.gov
Asahi Intecc Hanoi Co., Ltd.Hanoi Ha Noi, VietnamContract manufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer0000api.fda.gov
Balt ExtrusionMONTMORENCY Val-d'Oise, FranceContract manufacturer0000api.fda.gov
Bend It Technologies Ltd.Petach Tikva Central, IsraelComplaint file establishment, Manufacturer0000api.fda.gov
BIOMERICS Advanced CatheterBrooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
BMC Medical Manufacturing S.A. De C.V.Apodaca Nuevo Leon, MexicoContract manufacturer, Contract sterilizer0000api.fda.gov
Boston Scientific CorporationMississauga Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Cathx Medical IncSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Centerline BiomedicalCleveland, OH, United StatesManufacturer0000api.fda.gov
Clearstream Technologies Ltd.Wexford, IrelandManufacturer0000api.fda.gov
CPE1, LLC DBA Greatbatch MedicalSouthwest Ranches, FL, United StatesContract manufacturer0000api.fda.gov
Crossroads NeurovascularLake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Covidien Medical Products (Shanghai) Manufacturing LLCShanghai, ChinaContract manufacturer0000api.fda.gov
Creganna Medical S. R. LSan Rafael Heredia, Costa RicaContract manufacturer0000api.fda.gov
DK Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Emerald Medical Services Pte. LtdSingapore North West, SingaporeContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
Haolang Technology (foshan) Limited CorporationFoshan Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
Infinity Neuro, LLCLake Forest, CA, United StatesManufacturer for export0000api.fda.gov
Inari Medical, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Jabil Circuit (Shanghai) Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer0000api.fda.gov
Lake Region MedicalTrenton, GA, United StatesContract manufacturer0000api.fda.gov
M4D LLCLake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Maduro Medical, Inc.Los Gatos, CA, United StatesComplaint file establishment, 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
Meraqi Medical, Inc.Fremont, CA, United StatesContract manufacturer0000api.fda.gov
Midwest Sterilization Corp.Laredo, TX, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Midwest Sterilization Corp.Jackson, MO, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0010api.fda.gov
MicroVention Costa Rica S.R.L.. Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Natec Medical LtdMoka, MauritiusContract manufacturer, Manufacturer0000api.fda.gov
Norman Noble, Inc.Highland Heights, OH, United StatesContract manufacturer0000api.fda.gov
NeuroVasc Technologies, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Nitinol Devices & Components Costa Rica, S. R. L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Piraeus Medical, Inc.Maple Grove, MN, United StatesManufacturer0000api.fda.gov
Provisio Medical Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
Prytime Medical Devices, Inc.Lakewood, CO, United StatesSpecification developer0000api.fda.gov
Prytime Medical Devices, Inc.Boerne, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Quasar Medical (singapore) Pte. Ltd.Singapore North West, SingaporeContract manufacturer0000api.fda.gov
Resolution MedicalMinneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Rontis Hellas S.A.Larisa Thessalia, GreeceManufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shanghai Heartcare Medical Technology Corporation LimitedShanghai, ChinaManufacturer0000api.fda.gov
Sonorous NV, Inc.Lake Forest, CA, United StatesSpecification developer0000api.fda.gov
Suzhou Zenith Vascular Scitech LimitedSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Wallaby Medical Technologies CO., Inc.Shanghai, ChinaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Sterigenics U.S., LLCQueensbury, NY, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Toro Neurovascular, Inc.Irvine, CA, United StatesSpecification developer0000api.fda.gov
Toyoflex Cebu CorporationLapu-Lapu Cebu(Province), PhilippinesContract manufacturer0000api.fda.gov
VesalioSan Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Verge Medical Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated September 18, 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.