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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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
FSO
Device class
1
Regulation
878.4700
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China11
United States8
India5
Germany4
Brazil1
Netherlands1
Mexico1
Singapore1
Switzerland1
South Korea1
Pakistan1
United Kingdom1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Apramed Industria E Comercio De Aparelhos Medicos LtdaSAO CARLOS Sao Paulo, BrazilManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Atmos Medizintechnik GMBH & Co. KGLENZKIRCH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Blur Product DevelopmentCary, NC, United StatesContract manufacturer0000api.fda.gov
Braedius Medical B.V.Huizen Noord-Holland, NetherlandsManufacturer0000api.fda.gov
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Chengdu Corder Optics & Electronics Co., Ltd.Chengdu Sichuan, ChinaManufacturer0000api.fda.gov
Carl Zeiss Meditec (Suzhou) Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Denjoy Dental Co., LtdChangsha city Hunan, ChinaManufacturer0000api.fda.gov
Digital Surgery Systems, IncGoleta, CA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Gavin Biotechnology Co.,ltdJinzhong Shanxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Glycocheck Us, LLCAlpine, UT, United StatesSpecification developer0000api.fda.gov
Hefei Max Act Medical Equipment Co.,ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Dynamic Medical Technology Co., LtdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Labotech Microscopes India Private LimitedAMBALA CANTT Haryana, IndiaManufacturer0000api.fda.gov
Leica Instruments (singapore) Pte Ltd.SINGAPORE South West, SingaporeContract manufacturer0000api.fda.gov
Leica Microsystems (schweiz) AGHEERBRUGG Sankt Gallen, SwitzerlandSpecification developer0010api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Mediana Co., Ltd.Wonju-Si, Gangwon-do, South KoreaManufacturer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Shanghai Eder Medical Technology Inc.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Mediworks Precision Instruments Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Vivolight Medical Device&technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Suzhou Semorr Medical Technology Co.,Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Unify MedicalCleveland, OH, United StatesSpecification developer0000api.fda.gov
Viseon, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Volk Optical Inc.Mentor, OH, United StatesManufacturer0000api.fda.gov
Xrlabs LtdLondon London, City of, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Zumax Medical Co, Ltd.Suzhou,Jiangsu, ChinaManufacturer0000api.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.