MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOCONTROL , MODEL 1028

FDA 510(k)

FDA Class 2 ·Cardiovascular

DYNESYS TOP-LOADING SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTICARE DISPOSABLE PEN NEEDLES

FDA 510(k)

FDA Class 2 ·General Hospital

DEPUY RECLAIM REVISION HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MARDIS DANGLER URETERAL STENT SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

FDA 510(k)

FDA Class 2 ·Cardiovascular

MASS SPECTROMETRY MONITORING LINES AND CONNECTORS

FDA 510(k)

FDA Class 2 ·Anesthesiology

LOCKBOX

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL 9300 TREND ANALYZING BIO-MONITOR SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNI PHASE PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM

FDA 510(k)

FDA Class 2 ·Orthopedic

ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AEQUALIS HUMERAL NAIL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INSPECTRA STO2 TISSUE OXYGENATION MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOMETER GX BLOOD GLUCOSE METER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LCR

FDA 510(k)

FDA Class 2 ·Dental

INSUFLOW

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IMT.LAB

FDA 510(k)

FDA Class 2 ·Radiology