3,416 results · 49ms · Sources: EU EUDAMED, US FDA

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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

VITEK® 2 KB UPDATE V2S

FDA UDI
BIOMERIEUX , INC.·03573026613914·Knowledge Base Update for VITEK2 Software

VITEK® 2 KB UPDATE V2S

FDA UDI
BIOMERIEUX , INC.·03573026626471·Knowledge Base Update for VITEK2 Software

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

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

UNOMETER 500

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

NELATON-, FEMALE - OR TIEMANN CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FEEDING TUBE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VACCON

FDA 510(k)
FDA Class 1 ·General Hospital

OXYGEN CATHETERS

FDA 510(k)
FDA Class 1 ·Anesthesiology

SUCTION CATHETER STRAIGHT/COUDE

FDA 510(k)
FDA Class 1 ·Anesthesiology

EPDENT CO., LTD.

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

Enteral-ISOSAF 20ml ENFit Single Use Syringe (Sterile)

FDA registration
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD·1 product·🇨🇳 China

PRF-BOX

FDA registration
MCTBIO·1 product·🇰🇷 South Korea