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Data / Medical devices / Instrument, Surgical, Sonic And Accessory/Attachment

Instrument, Surgical, Sonic And Accessory/Attachment (JDX): 18 FDA-registered makers in 8 countries

18 establishments in 8 countries are registered with the FDA to make Instrument, Surgical, Sonic And Accessory/Attachment (product code JDX, Class 2, 21 CFR 888.4580). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on February 19, 2021, and lists 1 recall event (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
JDX
Device class
2
Regulation
888.4580
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States4
China4
Italy3
France2
Austria2
Switzerland1
Taiwan1
United Kingdom1

Makers of Instrument, Surgical, Sonic And Accessory/Attachment

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
Biomet, Inc.Warsaw, IN, United StatesManufacturer2September 22, 2003010api.fda.gov
Mectron S.P.A.CARASCO Genova, ItalyManufacturer2May 25, 2016000api.fda.gov
Orthofix SRLBUSSOLENGO Verona, ItalyExporter to the US, Manufacturer2February 19, 2010000api.fda.gov
Satelec-Acteon GroupMERIGNAC Gironde, FranceManufacturer2May 19, 2017000api.fda.gov
SMTP Medical Co., Ltd.Daxing District Beijing, ChinaManufacturer1February 19, 2021000api.fda.gov
AB Medical Technologies, Inc.Redding, CA, United StatesContract manufacturer0000api.fda.gov
Foreasytech S.R.L.Settimo di Pescantina Verona, ItalyContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Miing Wei Co., Ltd.Tsao-Twon Nantou, TaiwanContract manufacturer0000api.fda.gov
Radley Scientific LtdNewton Abbot Devon, United KingdomManufacturer0000api.fda.gov
Shenzhen Codyson Electrical Co, LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Perfect Idea Technology LimitedShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Sonicmed Medical Technology Co., LtdLas Vegas, NV, United StatesManufacturer0000api.fda.gov
Touchbeauty Beauty & Health (shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
W&H Dentalwerk Buermoos GMBHBUERMOOS Salzburg, AustriaManufacturer0000api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2BUERMOOS Salzburg, AustriaManufacturer0000api.fda.gov

Updated February 19, 2021. 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.