MODIFIED MANUFACTURING PROCESS FOR OMIDERM(TM)

FDA 510(k)

FDA Unclassified ·Unknown

MTC 7707 HIGH SPEED AIR TURBINE

FDA 510(k)

FDA Class 1 ·Dental

CarboClear VBR System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cuffix

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

LYNX LOW-SPEED HANDPIECE

FDA 510(k)

FDA Class 1 ·Dental

BRAVO PH MONITORING SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

Xeleris V Processing and Review System

FDA 510(k)

FDA Class 2 ·Radiology

VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

FIRMGRIP

FDA 510(k)

FDA Class 2 ·General Hospital

AURORA DS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILVERSTREAM AND DERMASEPT

FDA 510(k)

FDA Unclassified ·Unknown

APEXUM ABLATOR

FDA 510(k)

FDA Class 1 ·Dental

IGI-SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Piccolo Composite(R) Distal Volar Radius Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

ND: YAG ACCESSORY FOR PHOTODERM SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery