Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·SONNET 3 (EAS) Audio Processor, MAESTRO 11

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room

Monitor, Lung Water Measurement

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

Monitor, Lung Water Measurement

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

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

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

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

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS LP 01, PIKOS LP E01

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS

FDA 510(k)

FDA Class 3 ·Cardiovascular

SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS E 01-B

FDA 510(k)

FDA Class 3 ·Cardiovascular

RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777

FDA 510(k)

FDA Class 3 ·Cardiovascular

PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

FDA 510(k)

FDA Class 3 ·Cardiovascular