18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Diamond D
FDA UDI
Keystone Industries·H66810130971·Sample Denture Acrylic LRP, 20 min Liq. 150 g P&L
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457368·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457399·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457375·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457405·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457351·
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457344·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0130070·Rocker, One Piece
BETHENNY EYEWEAR
FDA UDI
FGX INTERNATIONAL INC.·00193033457382·
BRAIN COIL, MODEL 9800GE-64
FDA 510(k)
FDA Class 2
·Radiology
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
PROMUS ELEMENT ¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 20, 2013
SIGMA STAB XLK INS 2.5 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 24, 2011
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES, INC.·Product code MIH·March 14, 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