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Data / Medical devices / Light, Surgical, Floor Standing

Light, Surgical, Floor Standing (FSS): 31 FDA-registered makers in 8 countries

31 establishments in 8 countries are registered with the FDA to make Light, Surgical, Floor Standing (product code FSS, Class 2, 21 CFR 878.4580). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 20 510(k) clearances under this code, the latest on September 28, 2009, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FSS
Device class
2
Regulation
878.4580
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
India15
United States6
Germany5
Taiwan1
Japan1
Mexico1
France1
China1

Makers of Light, Surgical, Floor Standing

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
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer1February 1, 1999000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer1April 30, 1996000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer1June 28, 1996000api.fda.gov
Sunoptic Technologies, LLCJacksonville, FL, United StatesManufacturer1April 30, 1996000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Balaji SurgicalNew Delhi, IndiaManufacturer0000api.fda.gov
Berchtold GMBH & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Baxter Medical Systems GmbH + Co. KGMunich Bavaria, GermanySpecification developer0000api.fda.gov
Baxter Medical Systems GmbH + Co. KGSAALFELD Thuringia, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
BenQ Medical Technology CorporationTaoyuan City, TaiwanManufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Cognate IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
DKK Dai-Ichi Shomei Co, LtdITABASHI-KU Tokyo, JapanManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Galaxy IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Maquet S.A.S.ARDON, ORLEANS CEDEX 2 Loiret, FranceManufacturer0000api.fda.gov
Marken Healthtech LimitedNASHIK Maharashtra, IndiaManufacturer0000api.fda.gov
Meditech IndiaBHIWANI Haryana, IndiaManufacturer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Paras Surgico FactoryDelhi, IndiaManufacturer0000api.fda.gov
S.I.M.E.O.N. MEDICAL GMBH & Co.KGTUTTLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Staan Biomed Engineering Private LimitedCOIMBATORE Tamil Nadu, IndiaManufacturer0000api.fda.gov
Steris CorporationMontgomery, AL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Surgident IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
Shenzhen Kaiyan Medical Equipment Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Technomed IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
United Medi Equip Private LimitedNew Delhi, IndiaManufacturer0000api.fda.gov
United Surgical IndustriesSAHIBABAD Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Xcellance Medical Technologies Pvt. Ltd.Navi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov

Updated September 28, 2009. 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.