OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE

FDA 510(k)

FDA Class 2 ·General Hospital

THE KEYMED HI-LIGHT 250 LIGHT SOURCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY

VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

FDA 510(k)

FDA Class 2 ·Immunology

ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS

FDA 510(k)

FDA Class 2 ·Immunology

AIXPLORER

FDA 510(k)

FDA Class 2 ·Radiology

Irrigation Tubing with CO2 or Air

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LINQ II™ Insertable Cardiac Monitor (LNQ22)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS SUCTION PUMP MODEL KV-4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

K-1 INFANT TRANSPORT SYSTEM W/ INTEGRAL AIR COMPRE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

FDA 510(k)

FDA Class 2 ·Immunology

Red Dot

FDA 510(k)

FDA Class 2 ·Radiology

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS SUCTION PUMP, MODEL KV-5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology