17 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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