Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Pre-Market Approval

FDA Class 1 ·ABBOTT IMX TOTAL PSA

AirStrip ONE Web Client with Alarm Communication Management (ACM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MAINLINE MEDICAL DENTAL SUPPLY

FDA registration

MAINLINE MEDICAL DENTAL SUPPLY·2 products·🇨🇦 Canada

CALIBAJA MANUFACTURING, S.A. DE C.V.

FDA registration

CALIBAJA MANUFACTURING, S.A. DE C.V.·2 products·🇲🇽 Mexico

Carriere Motion 3D Clear Class II Malocclusion

FDA registration

ORTHO ORGANIZERS, INC.·2 products·🇺🇸 United States

JELDENT BASIC LINE

FDA 510(k)

FDA Class 2 ·Dental

AUTOSTAT II ANTI-TPO

FDA 510(k)

FDA Class 2 ·Immunology

Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350

FDA 510(k)

FDA Class 2 ·Physical Medicine

AUTOSTATTMII ANTI-DSDNA

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-THYROGLOBULIN

FDA 510(k)

FDA Class 2 ·Immunology

CYRTINA SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

BENCHMARK-IV

FDA 510(k)

FDA Class 2 ·Dental

PA-400

FDA 510(k)

FDA Class 2 ·Dental

LEGACY-XT

FDA 510(k)

FDA Class 2 ·Dental

BENCHMARK I

FDA 510(k)

FDA Class 2 ·Dental

OLYMPIA ALLOY

FDA 510(k)

FDA Class 2 ·Dental

JEL BIOS 18 (CODE NAME RD- 1214)

FDA 510(k)

FDA Class 2 ·Dental

JEL BIOS 10 (CODE NAME RD-1801)

FDA 510(k)

FDA Class 2 ·Dental

ALLROUND 55 LF

FDA 510(k)

FDA Class 2 ·Dental