942 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FRx Defibrillator (861304)
Over-The-Counter Automated External Defibrillator
FDA Pre-Market Approval
FDA Class 3
·HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A)
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Primary Battery (989803150161)
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·Simplify® Cervical Artificial Disc
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA Pre-Market Approval
FDA Class 3
·(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RES-Q ACD (ARRHYTHMIA CONTROL DEVICE) EPICARDIAL PATCH AND NON-THORACOTMY LEAD (NTL) SYSTEMS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AB-CORE K HEPATITIS B CORE ANTIGEN 125I
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AB-CORE K HEPATITIS B CORE ANTIGEN 125I
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AB-CORE K HEPATITIS B CORE ANTIGEN 125I
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·-LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·BIOTRON PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·T-SCAN 2000
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·Parvovirus B 19 IgG Enzyme Immunoassay
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS)
Imager, Breast, Electrical Impedance
FDA Pre-Market Approval
FDA Class 3
·TS2000