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Data / Medical devices / Device, Percutaneous, Biopsy

Device, Percutaneous, Biopsy (MJG): 40 FDA-registered makers in 11 countries

40 establishments in 11 countries are registered with the FDA to make Device, Percutaneous, Biopsy (product code MJG, Class 1, 21 CFR 878.4800). 1 of them has a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on May 9, 2008, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
United States14
Germany5
China4
Switzerland4
India2
Italy2
South Korea2
Pakistan2
Mexico2
France2
Japan1

Makers of Device, Percutaneous, Biopsy

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
Pajunk GMBH MedizintechnologieGEISINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer1May 9, 2008000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Biopsybell S.R.L.MIRANDOLA Modena, ItalyManufacturer0000api.fda.gov
BM Korea Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Canyon Medical Inc.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Carbon (shenzhen) Medical Device Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
GE Healthcare Japan CorporationHINO-SHI Tokyo, JapanManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Hicren (Zhejiang) Medtech Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Le Locle)Le Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
M.D.L. S.R.L.Delebio (So) Sondrio, ItalyManufacturer0010api.fda.gov
MEDLINE INDUSTRIES, LP - LaredoLaredo, TX, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Moeller Medical GMBHFULDA Hesse, GermanyManufacturer0000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Newtrans International CompanyNashville, TN, United StatesSpecification developer0000api.fda.gov
Nopa Instruments, Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
PROMOTEC-MEDIZINTECHNIK GmbHBlankenfelde / Mahlow Brandenburg, GermanyContract manufacturer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Seawon Meditech Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
SFM Medical Devices GmbHWaechtersbach Hesse, GermanyContract manufacturer0000api.fda.gov
SHANGHAI KiNETIC MEDICAL CO LTDShanghai, ChinaManufacturer0000api.fda.gov
Surgicon Pvt LtdSialkot Punjab, PakistanManufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer0000api.fda.gov
Teknimed SASL Union Haute-Garonne, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Top Clean InjectionPESCHADOIRES Puy-de-Dome, FranceContract manufacturer0000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov

Updated May 9, 2008. 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.