Skip to the page
Get started – free

Data / Medical devices / Needle, Tumor Localization

Needle, Tumor Localization (MIJ): 16 FDA-registered makers in 7 countries

16 establishments in 7 countries are registered with the FDA to make Needle, Tumor Localization (product code MIJ, 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 0 510(k) clearances under this code, and lists 3 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
MIJ
Device class
1
Regulation
878.4800
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States6
Pakistan2
Italy2
China2
Germany2
India1
Australia1

Makers of Needle, Tumor Localization

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
Allwin Medical Devices Pvt. Ltd.Surat Gujarat, IndiaManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0010api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
DFC Medical LLCHouston, TX, United StatesSpecification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
H.S. Hospital Service S.P.A.Rome Roma, ItalyManufacturer0000api.fda.gov
Hive International Pvt Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Inka Surgical InstrumentsJandakot Western Australia, AustraliaSpecification developer0000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer0000api.fda.gov
Medax S.R.L. UnipersonaleSan Possidonio Modena, ItalyManufacturer0000api.fda.gov
Ningbo Hysent Medical Technology Co., LtdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
PROMOTEC-MEDIZINTECHNIK GmbHBlankenfelde / Mahlow Brandenburg, GermanyContract manufacturer0000api.fda.gov
SOMATEX Medical Technologies GmbHBerlin, GermanyComplaint file establishment, Specification developer0000api.fda.gov
Shenzhen Xiazhifeng Electronic Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, 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

Updated November 2, 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.