Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED

FDA 510(k)

FDA Class 3 ·Orthopedic

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

DUPUY S-ROM STD HIP STEM PROSTHESIS

FDA 510(k)

FDA Class 3 ·Orthopedic

SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

TELEMETRY WAND MODEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

VACUUM BAKE CYCLE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ULTRA SOFTWARE MODULE: MODEL 2016

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA 2, ASTRA 3, 4 & 6

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEART SYNC, MODELS C-100 AND T-100

FDA 510(k)

FDA Class 3 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX, MINIX ST, NEW IC: L74

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T4 AND T6

FDA 510(k)

FDA Class 3 ·Cardiovascular

PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580

FDA 510(k)

FDA Class 3 ·Cardiovascular

DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)

FDA Class 3 ·Orthopedic

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES