Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

CINCHLOCK KNOTLESS SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

iPEP System and vPEP

FDA 510(k)

FDA Class 2 ·Anesthesiology

REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OrthoButton AL

FDA 510(k)

FDA Class 2 ·Orthopedic

20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABDOMINAL / THORACIC PATIENT DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM

FDA 510(k)

FDA Class 2 ·Orthopedic

SEREINE EXTRA STRENGTH DAILY CLEANER

FDA 510(k)

FDA Class 2 ·Ophthalmic

TKO Composite Bite Turbo Gel

FDA 510(k)

FDA Class 2 ·Dental

D R Burton OxyPAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NANOTACK SUTURE ANCHOR 1.4MM

FDA 510(k)

FDA Class 2 ·Orthopedic

RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS

FDA 510(k)

FDA Class 2 ·General Hospital

130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOPRO STEINMAN PINS AND KIRSCHNER WIRES

FDA 510(k)

FDA Class 2 ·Orthopedic

Ultra SEP

FDA 510(k)

FDA Class 2 ·Dental

EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aurora-RT

FDA 510(k)

FDA Class 2 ·Radiology