KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMNISURE URETHRAL SLING, MODEL OTK52

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VICKERS MEDICAL MODEL 271 HEART RATE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST

FDA 510(k)

FDA Class 2 ·Microbiology

EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

3400 INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

STIMULAN -CALCIUM SULFATE BONE VOID FILTER

FDA 510(k)

FDA Class 2 ·Orthopedic

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody

FDA 510(k)

FDA Class 2 ·Hematology

VOXAR'S CALCIUM SCORING PRODUCT

FDA 510(k)

FDA Class 2 ·Radiology

VENTSTREAM DRUG NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL

FDA 510(k)

FDA Class 2 ·Orthopedic

NEUROSIGN 100 IMPEDANCE METER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

JUVORA Dental Disc, Ceramill PEEK by JUVORA

FDA 510(k)

FDA Class 2 ·Dental

RESTORE-X

FDA 510(k)

FDA Class 2 ·Dental

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Urethrotech UCD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Revitive Medic Coach (Model Number 5575AQ)

FDA 510(k)

FDA Class 2 ·Physical Medicine

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology