KSEA THERMOFLATOR (MODEL 26 4320 20)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LAURIMED SPINAL INJECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

InkSpace Imaging Small Body Array

FDA 510(k)

FDA Class 2 ·Radiology

SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

CALDYNE, INC. EXHALOMETER EX100, MODEL EX100

FDA 510(k)

FDA Class 2 ·Anesthesiology

CATHERIZATION KS-50

FDA 510(k)

FDA Class 2 ·Radiology

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE

FDA 510(k)

FDA Class 2 ·Microbiology

NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMMULITE 2500 OM-MA, MODEL L5KOP

FDA 510(k)

FDA Class 2 ·Immunology

REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Boppli Infant Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

(.O38) HI-TORQUE GUIDE WIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL SSH-140A ULTRASOUND IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIDO BACK

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ahmed Glaucoma Valve

FDA 510(k)

FDA Class 2 ·Ophthalmic

CANCARY BREATHING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICROPLEX COIL SYSTEM (MCS), VFC

FDA 510(k)

FDA Class 2 ·Neurology