ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

FDA 510(k)

FDA Class 2 ·Hematology

TILL-U-TEST G.C. GONOCOCUS SLIDE

FDA 510(k)

FDA Class 2 ·Microbiology

LAB-TEK JEMBEC G.C. CULTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.

FDA 510(k)

FDA Class 2 ·Cardiovascular

TMS 1000 TEMP. MONITOR & PROBES

FDA 510(k)

FDA Class 2 ·General Hospital

D300 DOME

FDA 510(k)

FDA Class 2 ·Cardiovascular

CPS-1000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

ORTHODONITC METAL REINFORCED PLASTIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

ORTHODONTIC FACE BOW W/ INNER WIRE

FDA 510(k)

FDA Class 2 ·Dental

SMARTBOND

FDA 510(k)

FDA Class 2 ·Dental

GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

Personal Kinetigraph (PKG) System Gen 2 Plus

FDA 510(k)

FDA Class 2 ·Neurology

PERSONAL KINETIGRAPH (PKG) SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Personal Kinetigraph (PKG) System

FDA 510(k)

FDA Class 2 ·Neurology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology