Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER INTRAOCULAR LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Gonococcal Antibody Tests

FDA Pre-Market Approval

FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

P.F.C. APICAL PLUG

FDA 510(k)

FDA Class 3 ·Orthopedic

MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 483-02 PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 366-09 ADAPTAID ADAPTER SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

POLYFLEX IMPLANTABLE PACING LEAD-476-07

FDA 510(k)

FDA Class 3 ·Cardiovascular

COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE

FDA 510(k)

FDA Class 3 ·Cardiovascular