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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION EXCIMER LASER SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, CONAS AMPLIPREP/COBAS TAQMAN HBV TEST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PRESSURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM/COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TaqMan HBV Test for Use with the High Pure System/COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM, COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas TaqMan HBV Test for Use with the High Pure System and Cobas AmpliPrep, CobasTaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Analyzer, Data, Obstetric

FDA Pre-Market Approval

FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR