2,249 results · 45ms · Sources: EU EUDAMED, US FDA

Scan Cure (SC-80)

FDA registration
ODS CO., LTD.·1 product·🇰🇷 South Korea

Polarized Sunglasses, Photochromic Glasses: CC, CD, CF, CFS, CFK, CL, CS, CK, CKS, CH, COS, CT, D, DK, DQ, E, QC, EA

FDA registration
LINHAI CHENGYUAN GLASSES CO., LTD·1 product·🇨🇳 China

VENTANA PD-L1 (SP142) Assay W

FDA registration
VENTANA MEDICAL SYSTEMS, INC.·1 product·🇺🇸 United States

Drug-Coated Peripheral Transluminal Angioplasty Catheter

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)

System, Test, Her-2/Neu, Ihc

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

Immunohistochemistry Antibody Assay, C-Kit

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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS

Drug-Coated Peripheral Transluminal Angioplasty Catheter

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

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

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

DAB Chromogen kit, for 1250 tests

Device
EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries

DAB Chromogen kit, for 250 tests

Device
EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries

Titan HRP DAB 30 mL Kit

Device
EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·On the market·32 countries

005 PolyQ Stain DAB Substrate Buffer

Device
EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market

System, Test, Her-2/Neu, Ihc

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

Motion Trainer

FDA UDI
Trainer Rx, Inc. D/B/A Recoveryone·00196852042524·