Skip to the page

Data / Medical devices / Table, Operating-Room, Manual

Table, Operating-Room, Manual (FSE): 43 FDA-registered makers in 7 countries

43 establishments in 7 countries are registered with the FDA to make Table, Operating-Room, Manual (product code FSE, Class 1, 21 CFR 878.4950). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on March 13, 1986, and lists 1 recall event (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
FSE
Device class
1
Regulation
878.4950
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China16
India14
United States6
Germany4
Colombia1
Mexico1
Switzerland1

Makers of Table, Operating-Room, Manual

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
A.M. Surgical, Inc.Nashua, NH, United StatesSpecification developer0000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ari Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Balaji SurgicalNew Delhi, IndiaManufacturer0000api.fda.gov
Better Medical Technology Co., Ltd.Foshan City Guangdong, ChinaManufacturer0000api.fda.gov
Carevel Medical Systems Private LimitedGHAZIABAD Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Cognate IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
Dragon Medical Co.,LtdSuzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Foshan Any Home Care Medical Technology Co.,ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Galaxy IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guangdong Kangshen Medical Technology Co.,ltd.ZHAOQING Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Kareway Medical Technology Co., LtdFoshan Guangdong, ChinaManufacturer0000api.fda.gov
Hefei MT Medical Co.,ltd.Hefei Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hi-Life Technology (hebei) Co.,ltd.Bazhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hospedia Medicare Pvt LtdGURGAON, Haryana, IndiaManufacturer0000api.fda.gov
Industrias Metalicas Los Pinos SAITAGUI Antioquia, ColombiaManufacturer0000api.fda.gov
Instrument Specialists, Inc.Boerne, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jiangsu Keling Medical Appliances Co.,ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Maquet (suzhou) Co., LtdSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Maquet GMBHRASTATT Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Meditech IndiaBHIWANI Haryana, IndiaManufacturer0000api.fda.gov
Morzine Medical LLCMarietta, GA, United StatesSpecification developer0000api.fda.gov
Nanchang Micare Medical Equipment Co.,ltdNanchang Jiangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
P Bhogilal Pvt LtdKolkata West Bengal, IndiaManufacturer0000api.fda.gov
Paras Surgico FactoryDelhi, IndiaManufacturer0000api.fda.gov
Qufu Lekang Medical Technology Group Co.,ltd.JINING CITY Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
S & T AGNEUHAUSEN Schaffhausen, SwitzerlandManufacturer0000api.fda.gov
Schuerch CorporationAbington, MA, United StatesManufacturer0000api.fda.gov
Shandong Chenhong Medical Technology Co., Ltd.JINING CITY Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shandong Deman Medical Equipment Group Co., LtdJining City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Staan Biomed Engineering Private LimitedCOIMBATORE Tamil Nadu, IndiaManufacturer0000api.fda.gov
Surgident IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
Suzhou Number Win Medical Technology Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Technomed IndiaNew Delhi, IndiaManufacturer0000api.fda.gov
United Poly Engineering Pvt. Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Willson Medical System Private LimitedFATUHA Bihar, IndiaManufacturer0000api.fda.gov

Updated March 13, 1986. 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.