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
| Country | Makers |
|---|---|
| China | 8 |
| United States | 4 |
| India | 3 |
| Canada | 1 |
| Taiwan | 1 |
| Mexico | 1 |
| Turkey | 1 |
| Vietnam | 1 |
| Colombia | 1 |
| Germany | 1 |
| Czechia | 1 |
| Indonesia | 1 |
| Israel | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amico Patient Care Corporation | Richmond Hill Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chang Gung Medical Technology Co., Ltd. (Linkou Factory) | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang New Hope Medical Equipment Co., Ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Any Home Care Medical Technology Co.,ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing Aguascalientes, S.A de C.V | Aguascalientes, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gokler Group | Sivas, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GPC Medical Limited | Ghaziabad Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hard MFG. Co., Inc. | Buffalo, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoang Nguyen Health Services Equipment Manufacture And Trading Company Limited | Ly Thuong Kiet Ward Ninh Binh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hopefull Medical Equipment Co., Ltd. | Xianning City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Metalicas Los Pinos SA | ITAGUI Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd | Zhangjiagang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kayserbetten GmbH & Co. KG | Dorfmark Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LINET spol. s r.o. | Slany Stredocesky Kraj, Czechia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LX Precision Shanghai Co Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Kangmailong Medical Apparatus Co.,Ltd | Cixi City, Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novum Medical Products | Amherst, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pedicraft, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Mega Andalan Kalasan | JOGYAKARTA Yogyakarta, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QuantMed LifeTech (Shenzhen) Co., Ltd. | ShenzhenCity Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Savion Industries (1987), Ltd. | ASHDOD Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Medical | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Suzhou Number Win Medical Technology Co., Ltd. | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.