MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Biobeat Platform-2 and BB-613WP Patch

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODULAR ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

FDA 510(k)

FDA Class 2 ·Radiology

iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HemoScreen Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

TraumaCad Mobile Release 2.0

FDA 510(k)

FDA Class 2 ·Radiology

MCKESSON HORIZON CARDIOLOGY

FDA 510(k)

FDA Class 2 ·Radiology

SuperBall Meniscal Repair System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LONGY Implant and LONGY-N Implant

FDA 510(k)

FDA Class 2 ·Dental

BriefCase-Quantification

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mazor X System (Mazor X Stealth Edition)

FDA 510(k)

FDA Class 2 ·Neurology

Paltop Narrow Implant

FDA 510(k)

FDA Class 2 ·Dental

Ventoux VC2; Ventoux VC3

FDA 510(k)

FDA Class 2 ·Anesthesiology

HandX™ Self-Righting Needle Holder

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OSSIX Breeze

FDA 510(k)

FDA Class 2 ·Dental