11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIPPY, MODEL I88WA
FDA 510(k)
FDA Class 2
·Physical Medicine
GC Initial™
FDA UDI
Gc America Inc.·14548161315661·GC Initial™ LiSi Press Ingot LT-B4
GC Initial™
FDA UDI
Gc America Inc.·D0470128461·GC Initial™ LiSi Press Ingot LT-B4
EYE SENTIAL
FDA UDI
FGX INTERNATIONAL INC.·00193033444481·
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SIMPLICITY SILVER SET SOFT INFUSION
FDA 510(k)
FDA Class 2
·General Hospital
CONTACT DETACH
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 9, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 20, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011
H-TRONPLUS
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 11, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012