ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

SYNTHES 3.5MM CORTEX SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO S4 SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP

FDA 510(k)

FDA Class 2 ·Neurology

AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES (USA) LCP CURVED PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

COLLAR LESS AML HIP

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES (USA) SPHERICAL WASHERS

FDA 510(k)

FDA Class 2 ·Orthopedic

FLOSENSE II, MODEL 29-8040

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYNTHES LOW PROFILE RECONSTRUCTION PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

3.5 MM LCP DISTAL HUMERUS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POWER INFUSER, MODEL M100B-3A

FDA 510(k)

FDA Class 2 ·General Hospital

SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

SYNTHES (USA) TITANIUM WIRE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNIPOD INSULIN MANAGMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital