Actifuse

FDA registration

APATECH LTD.·1 product·🇬🇧 United Kingdom

Ostene

FDA registration

APATECH LTD.·1 product·🇬🇧 United Kingdom

Ostene

FDA registration

APATECH LTD.·1 product·🇬🇧 United Kingdom

PF4 IgG assay

FDA 510(k)

FDA Class 2 ·Hematology

Opera Lebody (Gold), Opera Lebody (Zafiro)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PF4 Enhanced assay

FDA 510(k)

FDA Class 2 ·Hematology

GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300

FDA 510(k)

FDA Class 2 ·Cardiovascular

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GTi Bioresorbable Vascular Scaffold (BVS) System

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System.

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM