1,748 results · 17ms · Sources: EU EUDAMED, US FDA

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

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/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...

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/COBAS TAQMAN HBV TEST V2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS TaqMan HBV Test for use on the High Pure System and COBAS AMpliPrep/COBAS TaqMan HBV Test, v2.0

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

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/COBAS TaqMan HBV Test, v2.0

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3150 PACING SYSTEM ANALYZER WAND AND THE MODEL 3307 V4.7 PROGRAMMER SOFTWARE FOR USE WITH MODEL 3510 PROGRAMMERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC 2030A BATTERYCHECK MONITOR TO BE USED WITH THE INSYNC II MARQUIS 7289, INSYNC MARQUIS MODEL 7277, MAXIMO DR...

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/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 and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

Tissue Adhesive Internal Use

FDA Pre-Market Approval
FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Tissue Adhesive Internal Use

FDA Pre-Market Approval
FDA Class 3 ·LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

Tissue Adhesive Internal Use

FDA Pre-Market Approval
FDA Class 3 ·LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

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/ COBAS® TaqMan® HBV Test, v2.0

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RADIESSE Injectable Implant, RADIESSE Hands, RADIESSE® (+) Lidocaine, RADIESSE (+) Jawline