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Data / Medical devices / Bed, Pediatric Open Hospital

Bed, Pediatric Open Hospital (FMS): 25 FDA-registered makers in 13 countries

25 establishments in 13 countries are registered with the FDA to make Bed, Pediatric Open Hospital (product code FMS, Class 2, 21 CFR 880.5140). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on April 25, 1997, and lists 4 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
FMS
Device class
2
Regulation
880.5140
Medical specialty
General Hospital

Makers by country

CountryMakers
China8
United States4
India3
Canada1
Taiwan1
Mexico1
Turkey1
Vietnam1
Colombia1
Germany1
Czechia1
Indonesia1
Israel1

Makers of Bed, Pediatric Open Hospital

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
Amico Patient Care CorporationRichmond Hill Ontario, CanadaManufacturer0000api.fda.gov
Chang Gung Medical Technology Co., Ltd. (Linkou Factory)New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Danyang New Hope Medical Equipment Co., LtdDanyang Jiangsu, ChinaManufacturer0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Foshan Any Home Care Medical Technology Co.,ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.VAguascalientes, MexicoContract manufacturer0000api.fda.gov
Gokler GroupSivas, TurkeyManufacturer0000api.fda.gov
GPC Medical LimitedGhaziabad Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hard MFG. Co., Inc.Buffalo, NY, United StatesManufacturer0000api.fda.gov
Hoang Nguyen Health Services Equipment Manufacture And Trading Company LimitedLy Thuong Kiet Ward Ninh Binh, VietnamManufacturer0000api.fda.gov
Hopefull Medical Equipment Co., Ltd.Xianning City Hubei, ChinaManufacturer0000api.fda.gov
Industrias Metalicas Los Pinos SAITAGUI Antioquia, ColombiaManufacturer0000api.fda.gov
Jiangsu Yongfa Medical Equipment Technology Co., LtdZhangjiagang City Jiangsu, ChinaManufacturer0000api.fda.gov
Kayserbetten GmbH & Co. KGDorfmark Lower Saxony, GermanyManufacturer0000api.fda.gov
LINET spol. s r.o.Slany Stredocesky Kraj, CzechiaManufacturer0000api.fda.gov
LX Precision Shanghai Co LtdShanghai, ChinaContract manufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo Kangmailong Medical Apparatus Co.,LtdCixi City, Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Novum Medical ProductsAmherst, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Pedicraft, Inc.Jacksonville, FL, United StatesManufacturer0000api.fda.gov
PT. Mega Andalan KalasanJOGYAKARTA Yogyakarta, IndonesiaManufacturer0000api.fda.gov
QuantMed LifeTech (Shenzhen) Co., Ltd.ShenzhenCity Guangdong, ChinaManufacturer0000api.fda.gov
Savion Industries (1987), Ltd.ASHDOD Southern, IsraelManufacturer0000api.fda.gov
Stryker MedicalPortage, MI, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Suzhou Number Win Medical Technology Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov

Updated April 25, 1997. 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.