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)

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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

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

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

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

N-Histofine DAB-２V

Device

EU IVDR · Eu Ivd Class A ·Nichirei Biosciences Inc.·On the market·10 countries

N-Histofine DAB-２V

Device

EU IVDR · Eu Ivd Class A ·Nichirei Biosciences Inc.·On the market·10 countries

N-Histofine DAB-２V

Device

EU IVDR · Eu Ivd Class A ·Nichirei Biosciences Inc.·On the market·10 countries

Alcian Blue-PAS (ABPAS)

FDA registration

PATHNSITU BIOTECHNOLOGIES PVT LTD·1 product·🇮🇳 India

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS

FDA 510(k)

FDA Class 2 ·Immunology

Danny Ties Tracheostomy Ties

FDA registration

Qingdao Leckie Foam Products Co. Ltd.·1 product·🇨🇳 China

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

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

PolyQ Stain DAB, 2 components

Device

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