1,019 results · 22ms · Sources: EU EUDAMED, US FDA

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·DAKO HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·Bond Oracle HER2 IHC System

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER -2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR SOFTWARE V4.0 SP1 ANTI - HBS

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

FDA Pre-Market Approval
FDA Class 3 ·IMMULITE 2000 HBsAg & HBs Ag Confirmatory

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

FDA Pre-Market Approval
FDA Class 3 ·ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATORS

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

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT ARCHITECT HBSAG/ ARCHITECT HBS/AG CONFIRMATORY

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

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT AUSAB and Alinity i Anti-HBs

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

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBSAG (HBS) AND HBSAG CONFIRMATORY

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE PERMANENT BIRTH CONTROL SYSTEM

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·STAN S31 FETAL HEART MONITOR

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·AMSUROLUME ENDOPROSTHESIS

Analyzer, Data, Obstetric

FDA Pre-Market Approval
FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM