108 results · 28ms · Sources: EU EUDAMED, US FDA

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK 8TM/MULTI-LINK 8TM LL/MULTI-LINK 8TM SV CORONARY STENT

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION/MINI VISION/MULTI-LINK 8TM/8TM LL/8TM SV CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION/MINI VISION/8TM/8TMLL/8TM SV CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK 8TM/MULTI-LINK 8 LLTM/MULTI-LINK 8TM SV CORONARY STENT SYSTEM

Tester, Acoustic, Bone Quality

FDA Pre-Market Approval
FDA Class 3 ·QUS-2 (TM) CALCANEAL ULTRASONOMETER

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC CUBES AND GRANULES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC CUBES AND GRANULES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC{TM} CUBES / GRANULES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC{TM} CUBES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC{TM} CUBES

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC CUBES{TM}

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval
FDA Class 3 ·DRILAC GRANULES

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ROCHE COBAS TAQMAN HBV TESTS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx, FoundationOne Liquid CDx

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES, RETROFLEX 3TM DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER, EDW