54 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BAYER HEALTHCARE RAPIDQC PLUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GC Initial™
FDA UDI
Gc America Inc.·J0228700361·GC Initial™ MC Opaqus Dentin ODB1, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556702038·GC Initial™ MC Opaqus Dentin ODB1, 20g
CARDIOTOMY RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
FDA 510(k)
FDA Class 1
·Cardiovascular
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 28, 2014
AVEA
FDA Adverse Event
Malfunction
·VIASYS/CAREFUSION·Product code CBK·October 8, 2010
PROGRASP (TM) FORCEPS
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 12, 2012
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R)PANTHER(TM) CORONARY BALL. DILI. CATH.
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R) EVERGREEN(TM) COR.BALL.DIL. CATH.
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R) EVERGREEN 40 CORONARY BALLOON DILATATION CATHETER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH.
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE