ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O

FDA 510(k)

FDA Class 2 ·Cardiovascular

BALLOON THERMODILUTION CATHETER #7164&

FDA 510(k)

FDA Class 2 ·Cardiovascular

Straumann Variobase for CEREC

FDA 510(k)

FDA Class 2 ·Dental

C0-AXIAL INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

A-CIFT SoloFuse

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SARNS VISIFLOW AORTIC ARCH CANNULA

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISSYS DRUG FLOW MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R

FDA 510(k)

FDA Class 2 ·Neurology

ETHYLENE OXIDE GAS STERILIZA SYS II

FDA 510(k)

FDA Class 2 ·General Hospital

MIC GASTROSTOMY TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EXTENDED LIFE CAPD SOLUTION TRANSFER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ELECTROLYTE ANALYZER SERA-210

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECTRONIC MUSCLE EXERCISER

FDA 510(k)

FDA Class 2 ·Physical Medicine

SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROVASIVE LITHOTRIPTOR FLEXPROBE II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO HBS HEADLESS BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

SICAT IMPLANT V1.2

FDA 510(k)

FDA Class 2 ·Radiology