RSB Calcaneo Stop

Device

EU MDR · Eu Md Class 3 ·LSM-MED S.r.l.·On the market·2 countries

RSB Calcaneo Stop

Device

EU MDR · Eu Md Class 3 ·LSM-MED S.r.l.·On the market·2 countries

CYTOTEST

Device

EU IVDR · Eu Ivd Class A ·Cytodiagnostic srl·On the market·32 countries

CYTOTEST

Device

EU IVDR · Eu Ivd Class A ·Cytodiagnostic srl·On the market·32 countries

CYTOTEST

Device

EU IVDR · Eu Ivd Class A ·Cytodiagnostic srl·On the market·32 countries

CYTOTEST

Device

EU IVDR · Eu Ivd Class A ·Cytodiagnostic srl·On the market·32 countries

Rapid Response

FDA UDI

BTNX Inc·10722066005115·COVID-19 IgG/IgM Test Cassette (Whole Blood/Ser...

Nano-CheckTM COVID-19 IgG/IgM Antibody Test

FDA UDI

NANO-DITECH CORPORATION·00895160002663·A in vitro diagnostic test for the qualitative ...

Fastep COVID-19 IgG/IgM Rapid Test Device

FDA UDI

ASSURE TECH. (HANGZHOU) CO., LTD.·06952804805029·

QuickProfile™ 2019-nCoV IgG/IgM Antibody Test

FDA UDI

LUMIQUICK DIAGNOSTICS, INC.·M90171108B0·QuickProfile™ 2019-nCoV IgG/IgM Test Card is an...

ACON SARS-CoV-2 IgG/IgM Rapid Test

FDA UDI

ACON LABORATORIES, INC.·00682607200979·Test Cassettes (25), 2.5mL Buffer Bottles (2), ...

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

FDA UDI

Biohit Healthcare (Hefei) Co., Ltd.·06973774259803·

Shenzhen Kentro Medical Electronics CO.,LTD.

Manufacturer

🇨🇳 China·5 Basic UDI-DIs·16 Devices·2 Importers·Intertek Medical Notified Body AB, INTERTEK SEMKO AB, and INTERTEK SEMKO AB

Tissue Adhesive For Internal Use

FDA Pre-Market Approval

FDA Class 3 ·COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

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

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford Partial Knee System

Cynosure LLC

Manufacturer

🇺🇸 United States·360 Basic UDI-DIs·360 Devices·3 Importers·INTERTEK SEMKO AB and INTERTEK SEMKO AB

American Surgical Company, LLC

Manufacturer

🇺🇸 United States·3 Basic UDI-DIs·3 Devices·5 Importers·INTERTEK SEMKO AB and INTERTEK SEMKO AB

Diagnosys LLC

Manufacturer

🇺🇸 United States·12 Basic UDI-DIs·12 Devices·INTERTEK SEMKO AB and INTERTEK SEMKO AB

X-Nav Technologies, LLC

Manufacturer

🇺🇸 United States·20 Basic UDI-DIs·34 Devices·INTERTEK SEMKO AB and INTERTEK SEMKO AB