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Data / Medical devices / Filiform And Filiform Follower

Filiform And Filiform Follower (FBW): 10 FDA-registered makers in 4 countries

10 establishments in 4 countries are registered with the FDA to make Filiform And Filiform Follower (product code FBW, Class 1, 21 CFR 876.5520). 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 September 25, 1991, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FBW
Device class
1
Regulation
876.5520
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States5
Germany2
Mexico2
Pakistan1

Makers of Filiform And Filiform Follower

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
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer0000api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov

Updated September 25, 1991. 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.