10,000 results · 69ms · Sources: EU EUDAMED, US FDA

Hovermatt Air transfer system

FDA registration
Skylla Morocco Sarl·1 product·🇲🇦 Morocco

EMOTECHNIC

FDA registration
EMOTECHNIC·1 product·🇲🇦 Morocco

MX608AB5 MX608AW5 MX608UB5 MX608UG5 MX608WN5 MX608WR5 WX608AB5 WX608WB5 WX608WP5 MC806W WC806W

FDA registration
PT. PARKLAND WORLD INDONESIA 2·1 product·🇮🇩 Indonesia

FREEVIEW INDUSTRIAL (VIETNAM) CO., LTD

FDA registration
FREEVIEW INDUSTRIAL (VIETNAM) CO., LTD·1 product·🇻🇳 Vietnam

KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

FDA 510(k)
FDA Class 2 ·Immunology

T/K (ATA/AMA) UNIVERSAL BIOPAK

FDA 510(k)
FDA Class 2 ·Immunology

Sharay AMA-M2 IgG (CLIA)

Device
EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

Evo Autoimmune Control, AMA IgG

Device
EU IVDR · Eu Ivd Class A ·ABD SRL·On the market·2 countries

Evo Autoimmune Standard, AMA IgG

Device
EU IVDR · Eu Ivd Class A ·ABD SRL·On the market·2 countries

AMA-M2 IgG CLIA Microparticles

Device
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AMA-M2 IgG CLIA Microparticles

Device
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

AutoLumo AMA-M2 IgG Calibrators

Device
EU IVDR · Eu Ivd Class B ·Autobio Diagnostics Co., Ltd.·On the market·2 countries

PANSEMENTS AMPOULES X 5 MA

Device
EU MDD · Eu Md Class 2a ·Eurosirel Spa·On the market·32 countries

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIRMATORY PMA ASSAYS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

MX608WN5

FDA registration
PT. SUKSES ABADI INDONESIA·1 product·🇮🇩 Indonesia

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA 2, RHA 3, RHA 4