3DNET SUITE

FDA 510(k)

FDA Class 2 ·Radiology

SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IMMULITE 2000 3RD GENERATION PSA

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 MIXED ALLERGEN PANELS

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

IMMULITE 2000 SPECIFIC ALLERGENS

FDA 510(k)

FDA Class 2 ·Immunology

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

FDA classification

FDA Class 2 ·Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Pentax Medical Video Duodenoscope ED32-i10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

XTJF TYPE Q160VF1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu Duodeno System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PENTAX ED-3490TK, VIDEO DUODENOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRE BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMIT-ST SERUM ETHYL ALCOHOL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology