Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Excimer Laser System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRO Topolyzer VARIO and Patient Bed Swivel

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBe assay and Control

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBc assay and Control

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc IgM assay and Control

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® QuantiFERON TB-Gold Plus assay and Control

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual assay and Control

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBeAg assay and Control

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·PRENTIF TM CAVITY RIM CERVICAL CAP

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PAPNET (R) TESTING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·FOCALPOINT SYSTEMCREENING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FocalPoint GS Imaging System