MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

KLS MINI OSTEOSYNTHESIS SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO ABL800 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROSTATE IMMOBILIZER RECTAL BALLOON

FDA 510(k)

FDA Class 2 ·Radiology

NemoCast

FDA 510(k)

FDA Class 2 ·Dental

POS-T-VAC B-10 BAND KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KLS CHIN PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

POS-T-VAC AVP-1000 & MVP-700

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

SPIROLAB, SPIROLAB II

FDA 510(k)

FDA Class 2 ·Anesthesiology

ILT ADVANCING MECHANISM, MODEL A115AMI

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIROBANK II

FDA 510(k)

FDA Class 2 ·Anesthesiology

ENDEARE BREAST PUMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Smart One

FDA 510(k)

FDA Class 2 ·Anesthesiology

NOVEL VBR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FASTPACK HCG IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]

FDA 510(k)

FDA Class 2 ·Cardiovascular