EVIS EXERA II 180 SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCANX 14

FDA 510(k)

FDA Class 2 ·Radiology

OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERIGAGE EO 100%

FDA 510(k)

FDA Class 2 ·General Hospital

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

CUTTING EDGE SPINE INTERBODY FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING

FDA 510(k)

FDA Class 2 ·General Hospital

PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR

FDA 510(k)

FDA Class 2 ·General Hospital

BIO-MODULAR SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY

FDA 510(k)

FDA Class 2 ·Cardiovascular

CAVEX TEMPORARY CEMENT

FDA 510(k)

FDA Class 2 ·Dental

BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POROUS TITANIUM ACETABULAR SHELLS

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOCCULT ICT

FDA 510(k)

FDA Class 2 ·Hematology

SARNS TEMPERATURE PROBE AND CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

JuggerStitch Meniscal Repair Device

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology