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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 700, 800 / 900 IPG FAMILY

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval
FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MODELS 8416,17,18,19 LEGEND PACEMAKERS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY PLUS MODEL 4296

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·ATTAIN ABILITY LEAD

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DEMA IPG; C-SERIES IPG; T-SERIES IPG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·LIAISON XL MUREX Anti-HBe and LIAISON XL MUREX Control Anti-HBe

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS TRANSLUMICAL ANGIOPLASTLY BALLOON CATHETER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·EP Passion Initiative

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·CARDIOGENESIS HOLMIUM TMR SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·GLUCOSE SENSOR ENLITE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·EVIA / ENTOVIS FAMILY OF PULSE GENERATORS

Device. Laser Peripheral Angioplasty

FDA Pre-Market Approval
FDA Class 3 ·TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·ACTIVA FAMILY/SOLETRA/KINETRA/LEADS/EXTENSIONS/ADAPTORS INS