54 results · 23ms · Sources: EU EUDAMED, 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