132 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM
Gastric Emptying Breath Test
FDA Pre-Market Approval
FDA Class 3
·13C-Spirulina Gastric Emptying Breath Test (GEBT)
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·DIASORIN ETI-CORE-IGMK PLUS
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT. TB TEST
Gastric Emptying Breath Test
FDA Pre-Market Approval
FDA Class 3
·13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APILGRAF(GRAFTSKIN)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE 2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE-M 2.0
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·RITHRON-XR CORONARY STENT SYSTEM
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·MODEL 3307, V4.0A PROGRAMMING SOFTWARE AND MODEL 3160 ECG ADAPTER CABLE
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·BRAVA CRT-D, BRAVA QUAD CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·AV PLUS DX, MODEL 1368
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·AFFINITY,IDENTITY,INTEGRITY & ENTITY IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
Programmer, Pacemaker
FDA Pre-Market Approval
FDA Class 3
·3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03