LUMEN-4 URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHENYTOIN FPIA REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INION CPS BSSO SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

OptoMonitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARESCAPE MONITOR B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD MAX Vaginal Panel

FDA 510(k)

FDA Class 2 ·Microbiology

CRANEX BASEX D OR CRANEX EXCEL D

FDA 510(k)

FDA Class 2 ·Dental

PLLA PIN

FDA 510(k)

FDA Class 2 ·Orthopedic

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

BD MAX Vaginal Panel, BD MAX Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214

FDA 510(k)

FDA Class 2 ·Orthopedic

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SCANORA 3D

FDA 510(k)

FDA Class 2 ·Dental