15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
FDA 510(k)
FDA Class 2
·Radiology
APEX REVISION KNEE SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
LENSTAR, MODEL LS900
FDA 510(k)
FDA Class 2
·Ophthalmic
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 12, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·December 12, 2024
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 21, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 28, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·October 17, 2014
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code PID·June 17, 2021
BD Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·November 12, 2023
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 2, 2019
WILSON-COOK ACHALASIA BALLOON
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PID·October 6, 2020
BD Q-SYTE LUER ACCESS
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·August 28, 2023
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·June 19, 2023