Imager, Breast, Electrical Impedance

FDA Pre-Market Approval

FDA Class 3 ·TS2000

DJP UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

EKG TRANSMITTER MODEL 5134

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000S

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

EDP-20 PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular

DJ UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

CODEMASTER XL + XL W/SHOCK ADVISORY OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIOTRONIK PERMANENT PACEMAKER ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS 01 & PIKOS E 01

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 1000

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS LP 01, PIKOS LP E01

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

MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS

FDA 510(k)

FDA Class 3 ·Cardiovascular

NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIOTRONIK'S PS-ENDOCARDIAL LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular