VIA-GUARD

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAPRO-LOADER(TM)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RIDIDFIX 2.7MM BTB CROSS PIN KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

MITEK BTB ABSORBABLE (PLA) CROSS PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MITEK BTB ABSORBABLE (PLA) CROSS PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO

FDA 510(k)

FDA Class 2 ·Orthopedic

Tester, Pacemaker Electrode Function

FDA Pre-Market Approval

FDA Class 2 ·ATA SOFTWARE CARTRIDGE (SWM 1000 I-KTB.0.U)

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

MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST

DYNAMEDICS ASAR

FDA 510(k)

FDA Class 2 ·General Hospital

GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle

FDA 510(k)

FDA Class 2 ·Orthopedic

StentBoost Mobile

FDA 510(k)

FDA Class 2 ·Radiology

MobileDiagnost M50

FDA 510(k)

FDA Class 2 ·Radiology

ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GPS/WGPS/PREVIEW GP

FDA 510(k)

FDA Class 2 ·Radiology