MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMFORT-EASE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

Magic Torque DLVR Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 9101 RECORDER/ANALYZER SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MODEL 90002065 MF TENS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER

FDA 510(k)

FDA Class 2 ·Radiology

NeuroBlate System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HotDog Temperature Management Controller

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETAL HEMOGLOBIN

FDA 510(k)

FDA Class 2 ·Hematology

DERMMATRIX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TGS Guidewire and updated Scopis Software

FDA 510(k)

FDA Class 2 ·Neurology

VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

FDA 510(k)

FDA Class 2 ·Immunology

CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS

FDA 510(k)

FDA Class 2 ·General Hospital

ENDOR 2000

FDA 510(k)

FDA Class 2 ·Neurology

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)

FDA 510(k)

FDA Class 2 ·Immunology

PERFECTA TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TEMPORARY SCREENING LEAD/CATHETER KIT

FDA 510(k)

FDA Class 2 ·Neurology