18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
Diamond D
FDA UDI
Keystone Industries·H66810130771·Denture Acrylic SC Orig 5 lb P&L
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453940·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453988·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453971·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453957·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453964·
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453926·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130070·Rocker, One Piece
SASSY JONES
FDA UDI
FGX INTERNATIONAL INC.·00193033453933·
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SMARTSCREW MODEL 222006...227510
FDA 510(k)
FDA Class 2
·Orthopedic
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 20, 2013
DELTA
FDA Adverse Event
Other
·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·March 1, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 11, 2014
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