10,000 results · 136ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Hepatitis B e Antigen (HBeAg) Assay

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT Free PSA and Alinity i Free PSA

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB and Alinity i Anti-HBs

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Precision Spectra / Novi / Wavewriter Spinal Cord Stimulator (SCS) System, Precision Montage Spinal Cord Stimulator (SCS

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval
FDA Class 3 ·Vercise Genus Deep Brain Stimulation (DBS) Systems

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Anti-Hepatitis B core Total (HBcT) Assay

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval
FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM MAMMARY PROSTHESES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·INTREL SPINAL CORD STIMULATION SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·NATRELLE INSPIRA BREAST IMPLANTS

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

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Atellica IM Alpha Fetoprotien (AFP) Assay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Atellica IM Hepatitis C (aHCV) Assay

ResScan

FDA UDI
RESMED PTY LTD·00619498313358·RESSCAN V6.0.2 CD ASSY

AVEA

FDA UDI
Carefusion Corporation·10846446064865·KIT,AVEA UPGRADE GDE,UIM & SOFTWARE

AVEA

FDA UDI
Carefusion Corporation·10846446000979·KIT,AVEA UPGRADE UIM & SOFTWARE

AirMini app

FDA UDI
RESMED PTY LTD·00619498222445·Android

Puritan Bennett

FDA UDI
Covidien LP·10884521640887·800 Series Options Kit, Italian, 840 Neonatal V...

AirView

FDA UDI
RESMED CORP.·00840193400108·AirView