RIGIDYNE A EXTERNAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VINYL BAG W/GRAVITY ADMINISTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Digital ClarusScope System, Digital NeuroPEN System

FDA 510(k)

FDA Class 2 ·Neurology

3M DENT II SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

BIOARC SP SLING KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE

FDA 510(k)

FDA Class 2 ·Anesthesiology

M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)

FDA 510(k)

FDA Class 2 ·Orthopedic

ANGIOJET XMI CATHETER - RAPID EXCHANGE (XMI-RX)

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERFECTA TOTAL HIP SYSTEM, HA COATED

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECSYS FOLATE III

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFIX ANTERIOR LUMBAR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SEGUE INFUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT

FDA 510(k)

FDA Class 2 ·Orthopedic

DISPOSABLE INTROSSEOUS INFUSION NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 6213 REMOTE ALARM

FDA 510(k)

FDA Class 2 ·Anesthesiology

EKOS+ Endovascular Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ONTRAK TESTCUP-ER M2K

FDA 510(k)

FDA Class 2 ·Clinical Toxicology