Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

MEDIX PHOTOTHERAPY LAMP

FDA 510(k)

FDA Class 2 ·General Hospital

ORskin Blue

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDIX PC-305 NEONATAL INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SW ULTRASOUND, MODELS 331, 311, 333

FDA 510(k)

FDA Class 2 ·Physical Medicine

WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB.CA-COLOR ARSENAZO III AA, MODEL 8 X 20 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFANT WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SURGIMAT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULMOCATH INTRABRONCHIAL CATHETER

FDA 510(k)

FDA Class 2 ·Radiology

WATER FILLED GUM SOOTHER

FDA 510(k)

FDA Class 2 ·Dental

Procedure Mask with Ear Loops and Surgical Mask with Ties

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SelectFlex Neurovascular Access System Family

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUNDASH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LA PERSONAL SCOOTER

FDA 510(k)

FDA Class 2 ·Physical Medicine

BLOOD GAS MIXTURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POS-T-VAC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PVMED DDR 2430T

FDA 510(k)

FDA Class 2 ·Radiology