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Data / Medical devices / Apparatus, Exhaust, Surgical

Apparatus, Exhaust, Surgical (FYD): 42 FDA-registered makers in 10 countries

42 establishments in 10 countries are registered with the FDA to make Apparatus, Exhaust, Surgical (product code FYD, Class 2, 21 CFR 878.5070). 23 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 75 510(k) clearances under this code, the latest on August 5, 2024, and lists 9 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
FYD
Device class
2
Regulation
878.5070
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
United States25
Mexico4
China4
Malaysia3
South Korea1
United Kingdom1
Switzerland1
Poland1
Canada1
Taiwan1

Makers of Apparatus, Exhaust, Surgical

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
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer11August 5, 2024000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer4March 3, 2014000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer, Manufacturer4August 5, 2024000api.fda.gov
I.C. Medical, Inc.Phoenix, AZ, United StatesManufacturer4October 30, 2017000api.fda.gov
CovidienBoulder, CO, United StatesManufacturer, Repackager or relabeler3January 14, 2015000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2January 14, 2015000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer2February 7, 2019000api.fda.gov
Acuderm, Inc.Fort Lauderdale, FL, United StatesManufacturer1February 9, 1994000api.fda.gov
Bio Protech Yantai IncYantai Shandong, ChinaManufacturer1August 29, 2019000api.fda.gov
Bio Protech, Inc.Wonju-si Gangwon, South KoreaManufacturer1August 29, 2019000api.fda.gov
Ethicon Endo-Surgery, Inc.Cincinnati, OH, United StatesSpecification developer1June 26, 2020000api.fda.gov
Ethicon Endo-Surgery, LLCGuaynabo, PR, United StatesSpecification developer1June 26, 2020000api.fda.gov
Global Life Sciences Solutions USA LLCMarlborough, MA, United StatesComplaint file establishment, Specification developer1August 20, 1999000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer1August 12, 1991000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1January 3, 2022000api.fda.gov
Megadyne Medical Products, Inc.Cincinnati, OH, United StatesSpecification developer1June 26, 2020000api.fda.gov
Medrange CorporationBrea, CA, United StatesSpecification developer1April 10, 2024000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer1June 29, 1998000api.fda.gov
Northgate Technologies Inc.Elgin, IL, United StatesComplaint file establishment, Manufacturer1March 25, 2021000api.fda.gov
Pall NewquayNewquay Cornwall, United KingdomManufacturer1August 20, 1999000api.fda.gov
Pall International, SarlFribourg, SwitzerlandExporter to the US, Specification developer1August 20, 1999000api.fda.gov
SurgiSmoke SolutionsSaint Paul, MN, United StatesComplaint file establishment, Specification developer1September 28, 1989010api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1August 28, 1995000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Clunas AGTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Instrumed SurgicalMississauga Ontario, CanadaContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jabil Inc.Auburn Hills, MI, United StatesContract manufacturer0000api.fda.gov
New Deantronics Taiwan Ltd.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
NPA de México S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Ocp De Mexico De Mexico S.A. De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Syntech, Int'l Inc.Irvine, CA, United StatesContract manufacturer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov
Ultraviolet Devices, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer0000api.fda.gov
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.HuiZhou Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.Huizhou Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Zhejiang Shuyou Surgical Instrument Co., LtdHuzhou Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov

Updated August 5, 2024. 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.