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

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT ADMIRAL DCB

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT AV DCB

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·HERCEPTEST

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 DCB PTA Catheter Balloon

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix DCB)