6,778 results · 21ms · Sources: EU EUDAMED, US FDA

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADAPTA, VERSA, SENSIA, ADVISA, ADVISA MRI,ENPULSE, KAPPA

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA PC, ACTIVA SC, ACTIVA RC, KINETRA, SOLETRA

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·INSYNC III (IPG)

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC HEARTMATE II LVAS

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SILASTIC BALL HEART VALVE PROSTHESIS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ENTRUST,GEM,GEM II,GEM III,INTRINSIC,MARQUIS,MAXIMO,MAXIMO II,ONYX,PROTECTA DF4,PROTECTA,PROTECTA XT DF4,PROTECTA XT

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·ANIMAL VIBE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·EXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT.

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% Sodium Hyaluronate)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, ANALYZER, VITATRON LEGACY, VITATRON

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ENRHYTHM

Neuromodulator For Obesity

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™