4,140 results · 22ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODEL C STAR

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i Anti-HBs Regent Kit, Alinity i Anti-HBs Calibrators, and Alinity i Anti-HBs Controls

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

FDA Pre-Market Approval
FDA Class 3 ·Alinity i HBsAg Qualitative II, Alinity i HBsAg Qualitative Confirmatory

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV