35 results · 20ms · Sources: EU EUDAMED, US FDA

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·OCS Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ESSENTIO™ SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT™ SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE™ SR; ACCOLADE DR; ACC

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·BRAVA CRT-D, QUAD CRT-D, CONCERTO OCD,CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, MAXIMO II CRT-D, PROTECT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S670 RAPID EXCHANGE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

Sterilizer, Glass Bead

FDA classification
FDA Class 3 ·Sterilizer, Glass Bead

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY OVER-THE -WIRE CORONARY STENT SYSTEM/S7 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY