TRANS1 AXIAL FIXATON SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUCOSE V

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CARDIOVASCULAR SET UP

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS

FDA 510(k)

FDA Class 2 ·Radiology

VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER

FDA 510(k)

FDA Class 2 ·Radiology

MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL

FDA 510(k)

FDA Class 2 ·Dental

OSTEO STEINMANN PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

WELCH ALLYN SPOT CHECK DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

'cottony' II TAPE, PLEDGETS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Xenoview VDP

FDA 510(k)

FDA Class 2 ·Radiology

Arisure® Closed Male Luer with Spike Adapter (YM060)

FDA 510(k)

FDA Class 2 ·General Hospital

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PALOMAR SLP 1000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POWERED LOW AIR LOSS MATTRESS SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FLORASEAL, MODEL FS350D

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery