MICROMAT W/VARIOUS MODELS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW

TRACKER 2/TRACKER 3 HOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

FDA 510(k)

FDA Class 2 ·Radiology

Artemis Hand Held Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Velguard Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SONOLITH I-MOVE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDIGUIDE TECHNOLOGY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Digitoxin (3-H), Rabbit Antibody, Charcoal Sep.

SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HI SONIC 2000 DIGITAL HEARING INSTRUMENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LIPOSONIX SYSTEM, MODEL 1 P00XXXX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHALLENGE 6010 POWERED MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

THE SELBY SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CYANODONT DENTAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

FDA 510(k)

FDA Class 2 ·Orthopedic

TOSOH AIA-PACK T3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry