10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
FDA 510(k)
FDA Class 2
·Radiology
BD LUER LOK 3 ML SYRINGE BULK CONVENIENCE PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·March 16, 2021
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FRIALIT-2 ESTHETICBASE ABUTMENT
FDA 510(k)
FDA Class 2
·Dental
CLARIUS ULTRASOUND SCANNER
FDA Adverse Event
Malfunction
·CLARIUS MOBILE HEALTH CORP.·Product code IYN·October 17, 2024
PARADIGM REAL-TIME REVEL INSULIIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 13, 2014
12/14 ARTICUL 44MM M SPEC+1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·August 12, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·July 9, 2013
BD ULTRA-FINE¿ MINI PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 5, 2022
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023