11 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMSURE 100% SILICONE FOLEY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282887·HIBBS RETRACTOR 9 1/2" 50 MILLIMETER
INFARED EAR THERMOMETER, MODEL TH8 SERIES
FDA 510(k)
FDA Class 2
·General Hospital
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 30, 2023
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·April 10, 2013
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR GALWAY·Product code NIM·May 22, 2008
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code MTA·April 5, 2011
AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 25, 2022
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 20, 2023
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