Dermagraft

FDA UDI

ORGANOGENESIS INC.·00618474000015·Dermagraft is indicated for use in the treatmen...

TransCyte

FDA UDI

ORGANOGENESIS INC.·00618474000046·TRANSCYTE® is a human fibroblast-derived tempor...

Apligraf

FDA UDI

ORGANOGENESIS INC.·00618474000008·Apligraf is indicated for use with standard the...

INOMAX DS (DELIVERY SYSTEM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INOMAX DS (DELIVERY SYSTEM), MODEL 10003

FDA 510(k)

FDA Class 2 ·Anesthesiology

INOMAX DSIR (DELIVERY SYSTEM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INOmax DSIR Plus MRI

FDA 510(k)

FDA Class 2 ·Anesthesiology

INOMAX DS (DELIVERY SYSTEM)

FDA 510(k)

FDA Class 2 ·Anesthesiology

INOMAX DS

FDA 510(k)

FDA Class 2 ·Anesthesiology

INOMAX DS (DELIVERY SYSTEM), MODEL 10003

FDA 510(k)

FDA Class 2 ·Anesthesiology

Premium Plus Prophy Air Motor

FDA 510(k)

FDA Class 1 ·Dental

V2465P X-RAY IMAGE INTENSIFIER

FDA 510(k)

FDA Class 2 ·Radiology

LED Curing Light (C01-X, C02-X)

FDA 510(k)

FDA Class 2 ·Dental

Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ERBOKRYO CA CRYOSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Self-Fitting hearing aids

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Disposable Endoscopic Cutter Stapler and Cartridge

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Medical Nitrile Examination Gloves

FDA 510(k)

FDA Class 1 ·General Hospital

Non-Contact Forehead Thermometer (Models UT306H & UT308H)

FDA 510(k)

FDA Class 2 ·General Hospital