10,000 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
FDA 510(k)
FDA Class 3
·Cardiovascular
NEOS-M PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP
FDA 510(k)
FDA Class 3
·Cardiovascular
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
FDA 510(k)
FDA Class 3
·Cardiovascular
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
HEART*AID 1000
FDA 510(k)
FDA Class 3
·Cardiovascular
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP
FDA 510(k)
FDA Class 3
·Cardiovascular
HEARTSTART 3000
FDA 510(k)
FDA Class 3
·Cardiovascular
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000
FDA 510(k)
FDA Class 3
·Cardiovascular
NEOS VS-1, PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
TRIOS-M VS-1 PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
BIO-PEN CALCULATOR
FDA 510(k)
FDA Class 3
·Unknown
BIO-PEN SRK II CALCULATOR
FDA 510(k)
FDA Class 3
·Unknown
System, Test, Her-2/Neu, Ihc
FDA Pre-Market Approval
FDA Class 3
·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
BLOOD GAS EXPERSYSTEM 8700
FDA 510(k)
FDA Class 3
·Unknown
INIVOX ELECTRODE/CATHETER SYS
FDA 510(k)
FDA Class 3
·Unknown
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·DIPLOS MODEL 03
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA Pre-Market Approval
FDA Class 3
·Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·Home Monitoring System Version 3.52.0