3,572 results · 39ms · Sources: EU EUDAMED, US FDA

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·Synergy Ablation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM

FDA Pre-Market Approval
RES-Q(TM) MICRON ICD SYSTEM

SUNGLASSES

FDA 510(k)
FDA Class 1 ·Ophthalmic

Dimension Vista AST Flex

FDA registration
SIEMENS HEALTHCARE DIAGNOSTICS INC.·4 products·🇺🇸 United States

ACE AST Reagent

FDA registration
ALFA WASSERMANN·4 products·🇺🇸 United States

Dimension® Dimension Vista® System Enzyme Diluent

FDA UDI
Siemens Healthcare Diagnostics Inc.·00842768000102·Enzyme Diluent, 10x10mL

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·Elecsys Anti-HCV II, PreciControl Anti-HCV

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

FDA Pre-Market Approval
FDA Class 3 ·Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck

Single-Use Internal Condom

FDA Pre-Market Approval
FDA Class 2 ·REALITY FEMALE CONDOM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE WIRE DELIVERY

Single-Use Internal Condom

FDA Pre-Market Approval
FDA Class 2 ·REALITY FEMALE CONDOM

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval
FDA Class 2 ·IPAFLUOROFOCON A AND B

Biograph mCT Flow Edge-4R

FDA registration
SIEMENS MEDICAL SOLUTIONS USA, INC.·2 products·🇺🇸 United States

Biograph mCT Flow Edge-4R

FDA registration
SIEMENS MEDICAL SOLUTIONS USA, INC.·2 products·🇺🇸 United States

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANCURE SYSTEM

FDA Pre-Market Approval
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V.2.0

FDA Pre-Market Approval
RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS