4,992 results
·
30ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS 019B, 019C, 019E, 019F, 019J, & 019K
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Exact Spine Sealant System
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Dural Sealant System
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·Hydrus® Microstent
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD
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