Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF ASPHERIC UV-ABSORBING RESTOR +2.5 INRAOCULAR LENS & ACRTSOF ASPHERIC UV-ABSORBING RESTOR +3.0 INTRAOCULAR LENS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HYDRO-THERMABLATOR(HTA) ENDOMETRIAL ABLATION SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

IMPLANTABLE PULSE DEVICES

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1

FDA 510(k)

FDA Class 3 ·Cardiovascular

MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS MODEL 4001

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 5866-24 PACEMAKER LEAD ADAPTOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

SURELIFT PROLAPSE SYSTEM

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

FOCUS J81F, J83F, J41F, J43F PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762

FDA 510(k)

FDA Class 3 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular