STRYKER SPINE XIA III SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CRANIAL SOLUTION ORTHOSIS

FDA 510(k)

FDA Class 2 ·Neurology

Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components

FDA 510(k)

FDA Class 2 ·Orthopedic

INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

SIRECUST 425, RESPECTIVELY SIRECUST 430

FDA 510(k)

FDA Class 2 ·Cardiovascular

I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE

FDA 510(k)

FDA Class 2 ·Immunology

ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)

FDA 510(k)

FDA Class 2 ·Ophthalmic

LACTATE DEHYDROGENASE (LD) TEST ITEM #65418

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)

FDA 510(k)

FDA Class 2 ·Neurology

SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HYSTEROSCOPE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ROSETTA-LT/ROSETTA-RX

FDA 510(k)

FDA Class 2 ·Cardiovascular

A-SCAN 100

FDA 510(k)

FDA Class 2 ·Radiology

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ENTERAL ADMINISTRATION ADAPTERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EASY-TEST CREATINE KINASE (CK) NUMBER: 16614

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Durex Polyisoprene Condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

FDA 510(k)

FDA Class 2 ·General Hospital