HOPER PTCA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LYRA ADENOVIRUS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

illumigene Pertussis DNA Amplification Assay

FDA 510(k)

FDA Class 2 ·Microbiology

COATEST(R) ANTITHROMBIN III, MODIFICATION

FDA 510(k)

FDA Class 2 ·Hematology

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

FDA 510(k)

FDA Class 2 ·Anesthesiology

AdvanCE capsule endoscope delivery device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BODYFORM THORACO-LUMBAR FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

FDA 510(k)

FDA Class 2 ·Hematology

STETH-SHIELD(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDION 6000

FDA 510(k)

FDA Class 2 ·Physical Medicine

TRILLIUM Oval MR System

FDA 510(k)

FDA Class 2 ·Radiology

iNSitu Total Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL #1556 HEAVY-DUTY JOYSTICK

FDA 510(k)

FDA Class 2 ·Physical Medicine

FLYNN TISSUE PROBE AND BLUNT DISSECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALLEGRO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ENDOPATH DILATING TIP TROCAR, MODEL #512XD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESA615

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mammotome AutoCore™ Single Insertion Core Biopsy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CERALOY SOLDER

FDA 510(k)

FDA Class 2 ·Dental