TOXOPLASMA GONDII IGG ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

Televere Digital Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

FDA 510(k)

FDA Class 2 ·Immunology

OTI BONE CEMENT PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STORZ SOLID-STANDOFF PACHYMETRY PROBE

FDA 510(k)

FDA Class 2 ·Radiology

ANEROID SPHYGMOMANOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRECLUDE PERICARDIAL MEMBRANE

FDA 510(k)

FDA Class 2 ·Cardiovascular

STAR (LUNAR SERIES) MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRYMED CRYO-ABLATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE WATER LILY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Stellaris Elite vision enhancement system

FDA 510(k)

FDA Class 2 ·Ophthalmic

CARDIOCEL

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS

FDA 510(k)

FDA Class 2 ·Ophthalmic

PUMA-G Pediatric System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MOBILE STANDING FRAME

FDA 510(k)

FDA Class 2 ·Physical Medicine

OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

FDA 510(k)

FDA Class 2 ·Orthopedic

Modified BrainScope One

FDA 510(k)

FDA Class 2 ·Neurology

Navigated Pedicle Access Kit

FDA 510(k)

FDA Class 2 ·Neurology