10,000 results · 35ms · Sources: EU EUDAMED, US FDA

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THE NORMALINE KIT

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·THE NORMALINE KIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·cobas HPV Mg/Mn

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses

FDA Pre-Market Approval
FDA Class 3 ·PLASMA SEPARATION SYSTEM

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE II UTERINE BALLOON THERAPY SYSTEM

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Catheter, Balloon, Transcervical

FDA Pre-Market Approval
FDA Class 3 ·GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval
FDA Class 3 ·POLYTEF PASTE FOR INJECTION

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·V1. 2A PROGRAMMER SOFTWARE

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·V.1 2A PROGRAMMER SOFTWARE

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRILL PASSIVE PLUS/AU PLUS DX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTRITEX TUL LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM