Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

DIGIARC 100AU+

FDA 510(k)

FDA Class 2 ·Radiology

MultiScan G-Arm System

FDA 510(k)

FDA Class 2 ·Radiology

S-Line

FDA 510(k)

FDA Class 2 ·Dental

Closed System Transfer Device

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bio-TackS Orthodontic Mini Implant

FDA 510(k)

FDA Class 2 ·Dental

TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)

FDA 510(k)

FDA Class 2 ·Neurology

Selethru(TM) NC PTCA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

WiZARD 520 Full Face Mask

FDA 510(k)

FDA Class 2 ·Anesthesiology

NaviCam ProScan

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Radiofrequency Generator System, Cura RF Electrode

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS

FDA 510(k)

FDA Class 2 ·General Hospital

SIRIUS Endoscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bone Marrow Biopsy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Autoclave Indicator Tape; EO Indicator Tape

FDA 510(k)

FDA Class 2 ·General Hospital

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry