P2psa

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

Abbott Diagnostics Medical Co., Ltd.

Manufacturer

🇯🇵 Japan·4 Basic UDI-DIs·4 Devices·1 Importer·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Abbott Toxicology Ltd

Manufacturer

1 Importer

IV COMFORT PAD

FDA 510(k)

FDA Class 1 ·General Hospital

AXIPUMP MANUAL BREAST PUMP

FDA 510(k)

FDA Class 1 ·Obstetrics/Gynecology

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

FDA Pre-Market Approval

FDA Class 3 ·NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

FDA Pre-Market Approval

MEDTRONIC KAPPA 400/DX2 AND KAPPA 700/600 PACEMAKERS

KIT COBAS LIAT SARS-COV-2/FLU

FDA registration

Roche Lumira Dx Bathgate·1 product·🇬🇧 United Kingdom

QIAstat-Dx Respiratory SARS-CoV-2 Panel

FDA registration

STAT-Dx Life, S.L.·1 product·🇪🇸 Spain

KIT COBAS LIAT SARS-COV-2/FLU

FDA registration

Roche Lumira Dx Stirling·1 product·🇬🇧 United Kingdom

QIAstat-Dx Meningitis-Encephalitis (ME) Panel

FDA registration

STAT-Dx Life, S.L.·1 product·🇪🇸 Spain

QIAstat-Dx Gastrointestinal Panel 2

FDA registration

STAT-Dx Life, S.L.·1 product·🇪🇸 Spain

QIAstat-Dx Respiratory Panel Plus

FDA registration

STAT-Dx Life, S.L.·1 product·🇪🇸 Spain

SleepView Web Portal

FDA registration

Beacon Bio Dx, LLC dba CleveMed·1 product·🇺🇸 United States

IDcheck

FDA registration

Beacon Bio Dx, LLC dba CleveMed·1 product·🇺🇸 United States

Sleep Scout

FDA registration

Beacon Bio Dx, LLC dba CleveMed·2 products·🇺🇸 United States

DENTURES, PARTIAL

FDA registration

NATURAL DENTAL LABORATORY CO.,LIMITED·1 product·🇨🇳 China