ENCOR UNIPOLAR VS-1 LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIVERSAL TERMINAL CAP, 3.2MM

FDA 510(k)

FDA Class 3 ·Cardiovascular

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561

FDA 510(k)

FDA Class 3 ·Cardiovascular

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING

FDA 510(k)

FDA Class 3 ·Cardiovascular

ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFE+CEL OR LIFECEL BATTERY

FDA 510(k)

FDA Class 3 ·Cardiovascular

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR Peptide Enhanced Bone Graft

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I