Bioscope Neuromonitor Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SpydrBlade Flex Instrument (PRD-RG1-001)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABI Instrument, Creo Electrosurgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Reusable Interface Cable 1.5 m (PRD-IFC-002)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Speedboat Flush SB1 Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Creo Electrosurgical System with HS1 Hemostasis Accessory

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AB1 Electrosurgical Instrument, Creo Electrosurgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NP1 Instrument, Creo Electrosurgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

FDA 510(k)

FDA Class 2 ·Immunology

Creo Electrosurgical System with NP1 Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CROMA Electrosurgical Generator (PRD-EMR-050)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILENT PARTNER MODEL 10-1001

FDA 510(k)

FDA Class 2 ·Anesthesiology

SILENT PARTNER MODEL 10-2001

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODEL GT010706 ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

GEMENI IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ANTISERUM TO HUMAN IGM

FDA 510(k)

FDA Class 2 ·Immunology