Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON -TB GOLD

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MISAGO RX SELF-EXPANDING PERIPHERAL STENT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR DEVICE - 8F AND 6F

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

BIOMETRIC SCREW FIXATION CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

ENCORE CLP OFFSET TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

THREADED PINS

FDA 510(k)

FDA Class 3 ·Unknown

KM-3 ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

ELA MEDICAL UNILITH PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

SUTURELESS MYOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

THOMPSON TYPE HIP PROTHESIS

FDA 510(k)

FDA Class 3 ·Orthopedic

MOTIONSPECT

FDA 510(k)

FDA Class 3 ·Unknown

KM-4(TM) METAL-BACKED ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

FDA 510(k)

FDA Class 3 ·Orthopedic

KIRSCHNER SELF-TAPPING ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic