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
| Country | Makers |
|---|---|
| United States | 14 |
| Germany | 8 |
| China | 6 |
| Brazil | 3 |
| India | 3 |
| Pakistan | 2 |
| Turkey | 2 |
| France | 1 |
| Switzerland | 1 |
| South Korea | 1 |
| Italy | 1 |
| Vietnam | 1 |
| Singapore | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BihlerMed, LLC | Phillipsburg, NJ, United States | Manufacturer | 2 | December 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Atricure, Inc. | Mason, OH, United States | Manufacturer | 1 | June 9, 2011 | 0 | 0 | 0 | api.fda.gov |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Manufacturer | 1 | March 8, 2013 | 0 | 0 | 0 | api.fda.gov |
| Maquet S.A.S. | ARDON, ORLEANS CEDEX 2 Loiret, France | Manufacturer | 1 | May 8, 2013 | 0 | 2 | 0 | api.fda.gov |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Complaint file establishment, Specification developer | 1 | June 25, 2010 | 0 | 0 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Contract manufacturer, Specification developer | 1 | June 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 1 | June 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barrfab Industria Comercio Importacao De Equipamentos Hospit | Farroupilha Rio Grande do Sul, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotex, Inc. | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | Munich Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | SAALFELD Thuringia, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentis Medical Division | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dewimed Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dragon Medical Co.,Ltd | Suzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Etkin Tibbi Cihazlar San. Ve Tic. A.S. | Cigli Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faro S.P.A. | Ornago (MB) Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Groman Inc. | Coconut Creek, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Life Technology (hebei) Co.,ltd. | Bazhou Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoang Nguyen Health Services Equipment Manufacture And Trading Company Limited | Ly Thuong Kiet Ward Ninh Binh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospedia Medicare Pvt Ltd | GURGAON, Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom Company, Inc. | Ladson, SC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inspital Medical Technology GMBH | Neuss North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klyo Medical Systems Inc | Doral, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kolplast Ci Ltda | Itupeva Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medpej Equipamentos Medicos Ltda | Ribeirao Preto Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mezlight, LLC | Madison, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROVITA Medical GmbH & Co. KG | WERMELSKIRCHEN North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paras Surgico Factory | Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qed, Inc. | Lexington, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Red Star Contract Manufacturing Inc. | Larwill, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Huifeng Medical Instrument Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Youmay Electronics Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicrafts | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai PAX Medical Instrument Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Aesthetics Medical-SD | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uzumcu Tibbi Cihaz Ve Medikal Gaz Sistemleri San. Tic. A.S. | Ankara, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivo Surgical Private Limited | Singapore South West, Singapore | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xcellance Medical Technologies Pvt. Ltd. | Navi Mumbai Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.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.