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Data / Medical devices / Adaptor, Bulbs, Miscellaneous, For Endoscope

Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY): 50 FDA-registered makers in 14 countries

50 establishments in 14 countries are registered with the FDA to make Adaptor, Bulbs, Miscellaneous, For Endoscope (product code FFY, Class 1, 21 CFR 876.1500). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on April 7, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FFY
Device class
1
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States16
Germany9
Japan6
China6
Hong Kong2
Italy2
Netherlands2
India1
Pakistan1
Thailand1
Poland1
Mexico1
United Kingdom1
Ireland1

Makers of Adaptor, Bulbs, Miscellaneous, For Endoscope

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
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1April 7, 1994000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer0000api.fda.gov
Applied Medical Resources Corp.Rsm, CA, United StatesComplaint file establishment, 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
Applied Medical Distribution CenterIrvine, CA, United StatesManufacturer0000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Bags And Gloves Co., Ltd.BANGKOKNOI Krung Thep Maha Nakhon, ThailandManufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
CALYX MEDICAL Sp. Z.O.O.Wroclaw Dolnoslaskie, PolandSpecification developer0000api.fda.gov
Changzhou Endoclean Medical Device Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd.changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanSpecification developer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Hanamaki OfficeHANAMAKI-SHI Iwate, JapanManufacturer0000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer0000api.fda.gov
Ga Health Company LimitedHong Kong, Hong KongComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Hangzhou Tonglu Shikonghou Medical Instrument Co., LtdHangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Healthmark Industries Co., Inc.Fraser, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Joimax GMBHKARLSRUHE Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Kinjo Rubber Co., Ltd.Yao-City Osaka, JapanContract manufacturer0000api.fda.gov
Mason Tayler Medical Products Corp.Buffalo, NY, United StatesSpecification developer0000api.fda.gov
Meditalia Group S.R..L.Palermo, ItalyManufacturer0000api.fda.gov
Meditech Endoscopy LtdBasildon Essex, United KingdomManufacturer0000api.fda.gov
Nolato ContourBaldwin, WI, United StatesContract manufacturer0000api.fda.gov
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Schoelly Fiberoptic, GMBHDENZLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Smartdata Suzhou Co., LtdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
SML Med-Tech Solutions LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
STERIS Italy S.r.l.Pomezia Roma, ItalyManufacturer, Specification developer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Trokamed GMBHGEISINGEN Baden-Wurttemberg, GermanyManufacturer0000api.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
Utah Medical Products, Ltd.ATHLONE CO. Leinster, IrelandContract manufacturer0000api.fda.gov
Vitreq BVVierpolders Zuid-Holland, NetherlandsManufacturer0000api.fda.gov
Wassenburg Medical B.V.Dodewaard Gelderland, NetherlandsManufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Chuangxiang Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov

Updated April 7, 1994. 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.