12 results
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26ms
·
Sources: EU EUDAMED, US FDA
CAP, INJECTION (#4600)
FDA 510(k)
FDA Class 2
·General Hospital
ILIF
FDA UDI
Nuvasive, Inc.·00887517262851·ILIF Shovel Tip
Peerless Buccal Tube
FDA UDI
ORMCO CORPORATION·00889989022209·ASSY ORTHCM LPBMPR OLFM -10T 22X45 RT
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192978·Femoral Locating Device Bushing 3 deg
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190813·FEMORAL CUT TEST GAGE SZ 4-5
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471177815·Anatomical Molar Bands, Upper Left 1St & 2Nd Mo...
ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
Spetzler Malis Dual Illuminating Bipolar Forceps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MITEK FMS DUO+ PUMP/SHAVER COMBO
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code HRX·April 18, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·September 26, 2012
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 9, 2010
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017