16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VASCUPUNCTURE ACCESS WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446331·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446324·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446348·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446317·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446362·
I IMAGE
FDA UDI
FGX INTERNATIONAL INC.·00193033446355·
EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
FDA 510(k)
FDA Class 2
·General Hospital
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
FDA 510(k)
FDA Class 1
·General Hospital
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 11, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT·Product code CBK·March 1, 2013
SMARTSETMV ENDURANCE 20 G
FDA Adverse Event
Injury
·DEPUY CMW·Product code MBB·February 24, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·March 12, 2008
COOLSCULPTING SYSTEM
FDA Adverse Event
Injury
·ALLERGAN PLESANTON·Product code OOK·May 12, 2021
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