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
| Country | Makers |
|---|---|
| India | 15 |
| United States | 6 |
| Germany | 5 |
| Taiwan | 1 |
| Japan | 1 |
| Mexico | 1 |
| France | 1 |
| China | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | February 1, 1999 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 1 | April 30, 1996 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Manufacturer | 1 | June 28, 1996 | 0 | 0 | 0 | api.fda.gov |
| Sunoptic Technologies, LLC | Jacksonville, FL, United States | Manufacturer | 1 | April 30, 1996 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Balaji Surgical | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Berchtold GMBH & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, 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 | |
| BenQ Medical Technology Corporation | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cognate India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DKK Dai-Ichi Shomei Co, Ltd | ITABASHI-KU Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galaxy India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet S.A.S. | ARDON, ORLEANS CEDEX 2 Loiret, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditech India | BHIWANI Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paras Surgico Factory | Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.I.M.E.O.N. MEDICAL GMBH & Co.KG | TUTTLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Staan Biomed Engineering Private Limited | COIMBATORE Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steris Corporation | Montgomery, AL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgident India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technomed India | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Medi Equip Private Limited | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Surgical Industries | SAHIBABAD Uttar Pradesh, India | 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 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.