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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PHILOS DR-T PULSE GENERATOR

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System

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)

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace® RNS® System

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM TEST SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) TRANSVENE LEAD SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212