12 results
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21ms
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Sources: EU EUDAMED, US FDA
URETEX SUP PUBOURETHRAL SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
"2.4MM" LOCKING RECON SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036010362·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033444948·
2010 PLUS HOLTER FOR WINDOWS
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
FDA 510(k)
FDA Class 2
·Cardiovascular
0009613348-2024-012949
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·September 30, 2024
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 25, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 26, 2013
EXETER V40 STEM 37.5MM NO 0
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code JDI·March 2, 2011
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·March 13, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014