10 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Longeviti ClearFit Cranial Implant
FDA 510(k)
FDA Class 2
·Neurology
24M - Tampa Electric Co.
FDA UDI
Certified Safety Manufacturing, Inc.·00766588013497·24M Tampa Electric Co.
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425629664·STRL VASCULAR INSERTION TRAY
ALLON 2001 MODIFIED
FDA 510(k)
FDA Class 2
·Cardiovascular
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
FLEXIMA BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FGE·October 15, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·July 2, 2013
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