Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR

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

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

FDA Pre-Market Approval

FDA Class 3 ·FPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS

POWERED EYE WASH

FDA 510(k)

FDA Class 3 ·Unknown

FPC/SFPC/RFPC ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR

FDA 510(k)

FDA Class 3 ·Unknown

MOBILE BATTERY SERVICE STATION (MBSS)

FDA 510(k)

FDA Class 3 ·Cardiovascular

MICRO-STRUC. ACETABULAR COMPON- MC2P

FDA 510(k)

FDA Class 3 ·Orthopedic

PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES

FDA 510(k)

FDA Class 3 ·Orthopedic

GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

LINK CEMENTLESS SCREW-IN ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

ACETABULAR DOME HOLE PLUGS

FDA 510(k)

FDA Class 3 ·Orthopedic

GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

ELECATH TORKFLOAT PACING PROBE

FDA 510(k)

FDA Class 3 ·Cardiovascular

OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES

FDA 510(k)

FDA Class 3 ·Orthopedic

P.T.H. METAL-BACKED ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

LINK CEMENTLESS SCREW-IN ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic