Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L

FDA 510(k)

FDA Class 2 ·Dental

ADX6000 Portable X-Ray System; iRayA6

FDA 510(k)

FDA Class 2 ·Radiology

IH Implant System

FDA 510(k)

FDA Class 2 ·Dental

Frozen C

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BCM-ARC 105 X-RAY MOBILE UNIT

FDA 510(k)

FDA Class 2 ·Radiology

BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO

FDA 510(k)

FDA Class 2 ·Radiology

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2

FDA 510(k)

FDA Class 2 ·Immunology

ISIS MER SYSTEM/ELEKTA MER SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

FDA 510(k)

FDA Class 2 ·Neurology

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE ONLINE TDM PHENYTOIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT STAT CK-MB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry