Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·Ascension MCP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL UJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES ETCO2 OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

FDA 510(k)

FDA Class 3 ·Cardiovascular

AECD ARRHYTHMIA DETECTION SOFTWARE

FDA 510(k)

FDA Class 3 ·Cardiovascular

STERILIZATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL PAD WITH CPR AID

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD

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

ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OSCOR PERMANENT PACING LEAD RZ MODEL SERIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular