422 results · 22ms · Sources: EU EUDAMED, US FDA

Ebony PTA 0.014 RX Peripheral Dilatation Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARTIGLASS L. O.R. GLASS SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval
FDA Class 2 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

DRY LASER IMAGER, MODEL DRYPRO MODEL 793

FDA 510(k)
FDA Class 2 ·Radiology

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

FDA 510(k)
FDA Class 2 ·Radiology

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)
FDA Class 2 ·Radiology

REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)
FDA Class 2 ·Radiology

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification
FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

FDA Pre-Market Approval
FDA Class 2 ·OSTEONICS CONSTRAINED ACETABULAR INSERT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV)

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)
FDA Class 2 ·Microbiology

PURITAN FOAM TIP SWAB MODEL 2197

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)
FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)
FDA Class 2 ·Immunology

Multi Modality Viewer

FDA 510(k)
FDA Class 2 ·Radiology

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VENTREX ALLERGEN DISC

FDA 510(k)
FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

FDA 510(k)
FDA Class 2 ·Immunology

ID NOW COVID-19 2.0

FDA 510(k)
FDA Class 2 ·Microbiology