PROSTATIC URETHRO. BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Infinity Acute Care System (IACS) Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTRA TECH IMPLANT DENTAL SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPECTRAL EEG MONITOR MODEL A1000

FDA 510(k)

FDA Class 2 ·Neurology

BARD(R) TIP DEFLECTING ELECTRODE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER

FDA 510(k)

FDA Class 2 ·General Hospital

DYONICS SHOULDER PORTAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

4-SURE FEMALE CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CANDELA CLEARBEAM PULSED DYE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PULPDENT SEAL RITE

FDA 510(k)

FDA Class 2 ·Dental

CHRISTOUDIAS PERITONEUM TWIN TISSUE APPROXIMATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRITSPIN MICRO-HEMATOCRIT

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SternSnap Angled Attachment

FDA 510(k)

FDA Class 2 ·Dental