12 results
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23ms
·
Sources: EU EUDAMED, US FDA
WATER POWERED BATH CHAIR LIFT
FDA 510(k)
FDA Class 1
·Physical Medicine
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515204324·Slaphammer for 79-0176 & 79-0177
Monaco RTP System
FDA 510(k)
FDA Class 2
·Radiology
ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8
FDA 510(k)
FDA Class 2
·Radiology
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC.·Product code MUJ·July 28, 2021
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 5, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVZ·October 15, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 10, 2010
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
MONACO
FDA Adverse Event
Malfunction
·ELEKTA INC·Product code MUJ·August 25, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025