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Data / Medical devices / Sound, Metal, Interconnected

Sound, Metal, Interconnected (FBS): 7 FDA-registered makers in 4 countries

7 establishments in 4 countries are registered with the FDA to make Sound, Metal, Interconnected (product code FBS, Class 1, 21 CFR 876.4590). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 24, 1996, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FBS
Device class
1
Regulation
876.4590
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States3
Pakistan2
Mexico1
Germany1

Makers of Sound, Metal, Interconnected

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
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov

Updated January 24, 1996. 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.