11 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TUBECLEAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANSONIC FLOW-QC SET MODEL ADT1010
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CELLEX
FDA Adverse Event
Malfunction
·THERAKOS, INC.·Product code LNR·May 10, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 26, 2014
UNKNOWN DEPUY FEMORAL STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·June 2, 2011
PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MBH·August 29, 2016
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 11, 2025
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
MALIBU
FDA Adverse Event
Injury
·SEASPINE INC.·Product code NKB·February 12, 2020
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023