IROOT FS

FDA 510(k)

FDA Class 2 ·Dental

IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES

FDA 510(k)

FDA Class 2 ·Radiology

4.0MM SIMPLER ONE PUSHIN DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SONIXGPS VASCULAR ACCESS NEEDLE KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

BIO-SEAL LUNG BIOPSY TRACT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

3.25MM SIMPLER ONE PUSHIN DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM

FDA 510(k)

FDA Class 2 ·Dental

FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

4.0MM SIMPLER THREADED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

GENTLE SLOPE

FDA 510(k)

FDA Class 2 ·Radiology

OCTOSTOP COMPENSATING FILTERS

FDA 510(k)

FDA Class 2 ·Radiology

PAM 3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

PIVOTING COMPENSATING FILTERS FOR THE HEAD

FDA 510(k)

FDA Class 2 ·Radiology

DURETTE IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

4.0MM SIMPLER ONE THREADED DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CALM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology