VISUAL BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATB ADVANCE PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATB ADVANCED PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATB ADVANCE PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYRIAN

FDA 510(k)

FDA Class 2 ·Radiology

DYMAXEON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CEREC VITABLOCKS MK2

FDA 510(k)

FDA Class 2 ·Dental

SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC BIB RANGER PTCA CATHETER

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

IT NASAL MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OGmend Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C

FDA 510(k)

FDA Class 2 ·Radiology

XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AOS Interstitial Templates, Needles, and Accessories

FDA 510(k)

FDA Class 2 ·Radiology

BAGRIGHT INFANT RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology