BABY DOPPLEX 3000 MK 2 (BD3000)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRASONIC TIPS

FDA 510(k)

FDA Class 2 ·Ophthalmic

FLEXILOG 3000

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER

FDA 510(k)

FDA Class 2 ·Ophthalmic

LiDCOunity Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eclipse MINI Model 98900

FDA 510(k)

FDA Class 2 ·Cardiovascular

OrthoView 7.2

FDA 510(k)

FDA Class 2 ·Radiology

MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001

FDA 510(k)

FDA Class 2 ·Anesthesiology

SP55 SYRINGE PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

RANDOX BENZODIAZEPINE CLASS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RENASYS Y-Connector; RENASYS TOUCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Randox Calcium (Ca)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENFLU 18 (enflufocon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

THE KEYMED HI-LIGHT 250 LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TITANIUM VENTILATION TUBES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADVIA Centaur Calcitonin (CALCT) assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: YELLOPORT PORT ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology