19 results · 23ms · Sources: EU EUDAMED, US FDA

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DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GD

FDA UDI
General Devices·00862186000386·The Rosetta-Lt Data Translator receives and com...

AUDIOSCREENER OAE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CHESS HAND SURGERY SYSTEM

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·November 23, 2016

ACL TOP

FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code GKP·May 13, 2005

ACL TOP

FDA Adverse Event
Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code GKP·July 21, 2005

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code CGA·July 27, 2016

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·September 28, 2016

ACL ADVANCE

FDA Adverse Event
INSTRUMENTATION LABORATORY CO.·Product code JPA·April 22, 2005

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 13, 2016

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·October 26, 2016

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 8, 2013

POLAR CARE 500

FDA Adverse Event
Other ·BREG, INC·Product code ILO·March 24, 2011

`TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·May 8, 2008

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·January 16, 2017

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·July 26, 2016

PRECISION XTRA

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·September 12, 2016

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018