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Data / Medical devices / Lamp, Surgical

Lamp, Surgical (FTD): 44 FDA-registered makers in 13 countries

44 establishments in 13 countries are registered with the FDA to make Lamp, Surgical (product code FTD, Class 2, 21 CFR 878.4580). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on December 5, 2013, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
United States14
Germany8
China6
Brazil3
India3
Pakistan2
Turkey2
France1
Switzerland1
South Korea1
Italy1
Vietnam1
Singapore1

Makers of Lamp, 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
BihlerMed, LLCPhillipsburg, NJ, United StatesManufacturer2December 5, 2013000api.fda.gov
Atricure, Inc.Mason, OH, United StatesManufacturer1June 9, 2011000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanyManufacturer1March 8, 2013000api.fda.gov
Maquet S.A.S.ARDON, ORLEANS CEDEX 2 Loiret, FranceManufacturer1May 8, 2013020api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandComplaint file establishment, Specification developer1June 25, 2010000api.fda.gov
Stryker Leibinger GMBH & Co. KGFREIBURG Baden-Wurttemberg, GermanyContract manufacturer, Specification developer1June 30, 1998000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer1June 30, 1998000api.fda.gov
B. Ali ImpexSIALKOT, Punjab, PakistanManufacturer0000api.fda.gov
Barrfab Industria Comercio Importacao De Equipamentos HospitFarroupilha Rio Grande do Sul, BrazilManufacturer0000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer0000api.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
Dentis Medical DivisionDaegu, South KoreaManufacturer0000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Dragon Medical Co.,LtdSuzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Etkin Tibbi Cihazlar San. Ve Tic. A.S.Cigli Izmir, TurkeyManufacturer0000api.fda.gov
Faro S.P.A.Ornago (MB) Milano, ItalyManufacturer0000api.fda.gov
Groman Inc.Coconut Creek, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hi-Life Technology (hebei) Co.,ltd.Bazhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hoang Nguyen Health Services Equipment Manufacture And Trading Company LimitedLy Thuong Kiet Ward Ninh Binh, VietnamManufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hospedia Medicare Pvt LtdGURGAON, Haryana, IndiaManufacturer0000api.fda.gov
Hill-Rom Company, Inc.Ladson, SC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Inspital Medical Technology GMBHNeuss North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Klyo Medical Systems IncDoral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Kolplast Ci LtdaItupeva Sao Paulo, BrazilManufacturer0000api.fda.gov
Medpej Equipamentos Medicos LtdaRibeirao Preto Sao Paulo, BrazilManufacturer0000api.fda.gov
Mezlight, LLCMadison, WI, United StatesSpecification developer0000api.fda.gov
PROVITA Medical GmbH & Co. KGWERMELSKIRCHEN North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Paras Surgico FactoryDelhi, IndiaManufacturer0000api.fda.gov
Qed, Inc.Lexington, KY, United StatesManufacturer0000api.fda.gov
Red Star Contract Manufacturing Inc.Larwill, IN, United StatesContract manufacturer0000api.fda.gov
Shanghai Huifeng Medical Instrument Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Youmay Electronics Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Shanghai PAX Medical Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.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
Tiger Aesthetics Medical-SDSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Uzumcu Tibbi Cihaz Ve Medikal Gaz Sistemleri San. Tic. A.S.Ankara, TurkeyManufacturer0000api.fda.gov
Vivo Surgical Private LimitedSingapore South West, SingaporeManufacturer0000api.fda.gov
Xcellance Medical Technologies Pvt. Ltd.Navi Mumbai Maharashtra, IndiaManufacturer0000api.fda.gov

Updated December 5, 2013. 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.