AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

FDA 510(k)

FDA Class 2 ·Neurology

WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

THE STRIPPER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADVANCED MEDICAL SYSTEMS, KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

i-STAT CHEM8+ cartridge with the i-STAT 1 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STATUS HCG SERUM/URINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BREAS PV 10I CPAP SYSTEM, MODEL PV 10I

FDA 510(k)

FDA Class 2 ·Anesthesiology

DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

COBAS READY GLUCOSE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VWF-IX:AG CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

FDA 510(k)

FDA Class 2 ·Orthopedic

SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRIO MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RYDER CONTACT LENS CASE MODEL 10670

FDA 510(k)

FDA Class 2 ·Ophthalmic

EBI ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic