5,214 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ]
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·AXSYM AFP
LIFEPAK 12 BIPHASIC
FDA 510(k)
FDA Class 3
·Cardiovascular
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
FDA 510(k)
FDA Class 3
·Cardiovascular
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
PELLETHANE 75D
FDA 510(k)
FDA Class 3
·Cardiovascular
STELA MODEL UJ45 PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
ZOLL M SERIES ETCO2 OPTION
FDA 510(k)
FDA Class 3
·Cardiovascular
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
FDA 510(k)
FDA Class 3
·Cardiovascular
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
FDA 510(k)
FDA Class 3
·Cardiovascular
AECD ARRHYTHMIA DETECTION SOFTWARE
FDA 510(k)
FDA Class 3
·Cardiovascular
STERILIZATION
FDA 510(k)
FDA Class 3
·Cardiovascular
ZOLL PAD WITH CPR AID
FDA 510(k)
FDA Class 3
·Cardiovascular
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
FDA 510(k)
FDA Class 3
·Cardiovascular
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
FDA 510(k)
FDA Class 3
·Cardiovascular
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular