GlucoSure Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM014 Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UASure II Blood Uric Acid Monitoring System

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MultiSure GK Link Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GAL-1A Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KET-1 Blood Ketone Monitoring System

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

GlucoSure HT Plus Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

InnoSight Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

GlucoSure ADVANCE Link Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MTM301 Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Access AccuTnI+3 on UniCel DxI (reagent pack)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·1 device

Footshell Runway Regular

FDA registration

OTTO BOCK HEALTHCARE CANADA·1 product·🇨🇦 Canada

Footshell Runway Regular

FDA registration

Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH·1 product·🇩🇪 Germany

Footshell Runway Regular

FDA registration

Otto Bock Healthcare Products GmbH·1 product·🇦🇹 Austria

Footshell Runway Regular

FDA registration

Ottobock Manufacturing Bulgaria EOOD·1 product·🇧🇬 Bulgaria

Footshell Runway Regular

FDA registration

OTTO BOCK HEALTHCARE LP·1 product·🇺🇸 United States

DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)

FDA 510(k)

FDA Class 2 ·General Hospital

FibreKor Fiber Post Drill

FDA registration

Kerr Corporation·1 product·🇺🇸 United States