Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·Model 203 Life Pulse High Frequency Ventilator

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL LEAK SEALANT

Device, Cystometric, Air

FDA classification

FDA Class 3 ·Device, Cystometric, Air

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GEL

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

BIPOLAR LEADS, DISP.

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 493-03 PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

CARCIAC PULSE GENERATOR 254-20

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 5984/5985

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC #4951

FDA 510(k)

FDA Class 3 ·Cardiovascular

CORDIS MULTIFILAR PERVENOUS VENTRIC. LD

FDA 510(k)

FDA Class 3 ·Cardiovascular

VENTRICULAR INHIBITED PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

BALL TIP, MODEL #030-188

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC SPECTRAX

FDA 510(k)

FDA Class 3 ·Cardiovascular

GENERATORS, PULSE, MODELS 5988/5989

FDA 510(k)

FDA Class 3 ·Cardiovascular

THERAPEUTIC EXCHANGE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown