17 results · 32ms · Sources: EU EUDAMED, US FDA

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LUNA DENTAL IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

ALOCLAIR ORAL RINSE

FDA 510(k)
FDA Unclassified ·Unknown

SUMO ACCESS AND TISSUE RESECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·May 18, 2026

KANGAROO

FDA Adverse Event
Injury ·CARDINAL HEALTH 200, LLC·Product code KNT·April 6, 2026

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·April 17, 2026

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 20, 2025

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·May 1, 2026

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 11, 2021

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 21, 2013

INTERMATE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·June 10, 2011

INTERCHANGEABLE ULNAR ASSEMBLY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·December 30, 2024

INTERCHANGEABLE HUMERAL ASSEMBLY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

KANGAROO

FDA Adverse Event
Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·November 25, 2025