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Data / Medical devices / Lamp, Operating-Room

Lamp, Operating-Room (FQP): 30 FDA-registered makers in 6 countries

30 establishments in 6 countries are registered with the FDA to make Lamp, Operating-Room (product code FQP, Class 2, 21 CFR 878.4580). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on June 23, 2000, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

CountryMakers
China15
United States6
Switzerland3
India3
Germany2
Vietnam1

Makers of Lamp, Operating-Room

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
Sunoptic Technologies, LLCJacksonville, FL, United StatesManufacturer1June 23, 2000000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1December 6, 1999000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1December 6, 1999000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1June 23, 2000000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1June 23, 2000000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Better Medical Technology Co., Ltd.Foshan City Guangdong, ChinaManufacturer0000api.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
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Eclipse Prism Medical Devices Pvt. LtdRABALE, NAVI MUMBAI Maharashtra, IndiaManufacturer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Guangzhou Ajax Medical Equipment Co LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Harbin Howell Medical Apparatus And Instruments Co.,ltd.Harbin Heilongjiang, ChinaManufacturer0000api.fda.gov
Hebei Webian Medical Instrument Trading Co., LtdSHIJIAZHUANG CITY Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei MT Medical Co.,ltd.Hefei Anhui, 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
Hill-Rom Company, Inc.Ladson, SC, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu Rooe Medical Technology Co., Ltd.Zhangjiagang City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Saikang Medical Equipment Co., LtdZhangjiagang Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Yongfa Medical Equipment Technology Co., LtdZhangjiagang City Jiangsu, ChinaManufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Nanjing Yanan Special Lighting FactoryNanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Shanghai No. 2 Medical College Duhang Medical Equipment FactoryShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenyang Ourpromise Medical Equipment Co., Ltd.Shenyang Liaoning, ChinaExporter to the US, Manufacturer0000api.fda.gov
Suzhou Number Win Medical Technology Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai PAX Medical Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Zhejiang Honsun Medical Technology Co., Ltd.Wenzhou City Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov

Updated June 23, 2000. 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.