1,202 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Mr-Guided Focused Ultrasound System
FDA Pre-Market Approval
FDA Class 3
·Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
LEAD MODIFICATION
FDA 510(k)
FDA Class 3
·Cardiovascular
PULSTRON MODEL 100
FDA 510(k)
FDA Class 3
·Cardiovascular
IMPLANTABLE PULSE DEVICES
FDA 510(k)
FDA Class 3
·Cardiovascular
DIRECTIONAL BOOT
FDA 510(k)
FDA Class 3
·Cardiovascular
CARCIAC PULSE GENERATOR 254-20
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDTRONIC MODELS 5984/5985
FDA 510(k)
FDA Class 3
·Cardiovascular
#325 PROGRAMMABLE CARD. PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
EKG TRANSMITTER MODEL 5134
FDA 510(k)
FDA Class 3
·Cardiovascular
VS-1 MODEL NUMBER 251K PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
COMMAND NP
FDA 510(k)
FDA Class 3
·Cardiovascular
OPTIMA MPT MODEL 5281E AND MODEL 5282E
FDA 510(k)
FDA Class 3
·Cardiovascular
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
FDA 510(k)
FDA Class 3
·Cardiovascular
EDP-20 PACEMAKER
FDA 510(k)
FDA Class 3
·Cardiovascular
COOK #326T PROGRAM/TELEMETRY BIPOLAR
FDA 510(k)
FDA Class 3
·Cardiovascular
IMPLANTABLE PROGRAMMABLE PULSE GENER
FDA 510(k)
FDA Class 3
·Cardiovascular
BATTERY FOR #229-01 PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
UNIFOCAL 3
FDA 510(k)
FDA Class 3
·Cardiovascular