10,000 results · 30ms · Sources: EU EUDAMED, US FDA

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