SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FPC HIP STEM COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

BD Contoured Base Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXPEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO OSTEONICS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MULTINEX MONITOR (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Anesthesiology

PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP

FDA 510(k)

FDA Class 2 ·Radiology

THROMBIN-PREST REAGENT KIT

FDA 510(k)

FDA Class 2 ·Hematology

AKCESS-CATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

My3D® Personalized Pelvic Reconstruction

FDA 510(k)

FDA Class 2 ·Orthopedic

XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory

FDA 510(k)

FDA Class 2 ·Orthopedic

ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEISTER SURGICAL INT'L MONOPOLAR ENDOSCOPIC SURG.INST.

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

USCI SOFT-TIP ANGIOGRAPHIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLITAIRE ANTERIOR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS

FDA 510(k)

FDA Class 2 ·General Hospital