Data / Medical devices / Microscope, Surgical, General & Plastic Surgery
Microscope, Surgical, General & Plastic Surgery (FSO): 36 FDA-registered makers in 12 countries
36 establishments in 12 countries are registered with the FDA to make Microscope, Surgical, General & Plastic Surgery (product code FSO, Class 1, 21 CFR 878.4700). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on June 13, 1994, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FSO
- Device class
- 1
- Regulation
- 878.4700
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 11 |
| United States | 8 |
| India | 5 |
| Germany | 4 |
| Brazil | 1 |
| Netherlands | 1 |
| Mexico | 1 |
| Singapore | 1 |
| Switzerland | 1 |
| South Korea | 1 |
| Pakistan | 1 |
| United Kingdom | 1 |
Makers of Microscope, Surgical, General & Plastic Surgery
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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apramed Industria E Comercio De Aparelhos Medicos Ltda | SAO CARLOS Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atmos Medizintechnik GMBH & Co. KG | LENZKIRCH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blur Product Development | Cary, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braedius Medical B.V. | Huizen Noord-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (oberkochen) | OBERKOCHEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengdu Corder Optics & Electronics Co., Ltd. | Chengdu Sichuan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denjoy Dental Co., Ltd | Changsha city Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Surgery Systems, Inc | Goleta, CA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gavin Biotechnology Co.,ltd | Jinzhong Shanxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glycocheck Us, LLC | Alpine, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Max Act Medical Equipment Co.,ltd. | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 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 | |
| Jiangsu Dynamic Medical Technology Co., Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labotech Microscopes India Private Limited | AMBALA CANTT Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Instruments (singapore) Pte Ltd. | SINGAPORE South West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leica Microsystems (schweiz) AG | HEERBRUGG Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mediana Co., Ltd. | Wonju-Si, Gangwon-do, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P Bhogilal Pvt Ltd | Kolkata West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panorama International. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Eder Medical Technology Inc. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Vivolight Medical Device&technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Semorr Medical Technology Co.,Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unify Medical | Cleveland, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viseon, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volk Optical Inc. | Mentor, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xrlabs Ltd | London London, City of, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zumax Medical Co, Ltd. | Suzhou,Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 13, 1994. 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.