GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIENER LAB. URINE STRIP 10 AND 11

FDA 510(k)

FDA Class 2 ·Hematology

WIENER LAB AMILASA 405 AA LIQUIDA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEFLEX ACRILATO

FDA 510(k)

FDA Class 2 ·Dental

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)

FDA 510(k)

FDA Class 2 ·Physical Medicine

WIENER LAB. BILIRUBINA DIRECT AA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

FDA 510(k)

FDA Class 2 ·General Hospital

ODONT HEX SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

WIENER LAB. UREA UV CINETICA AA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

B&W DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

FDA 510(k)

FDA Class 2 ·General Hospital

SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

GALIX MA-6C HOLTER CASSETTE RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIENER LAB. BILIRRUBINA TOTAL AA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye

FDA 510(k)

FDA Class 2 ·General Hospital

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