14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIVO 50
FDA 510(k)
FDA Class 2
·Anesthesiology
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·July 31, 2017
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·September 15, 2015
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
PAGEWRITER TC 20, 30, 50, 70
FDA 510(k)
FDA Class 2
·Cardiovascular
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM
FDA Adverse Event
Malfunction
·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code DRS·December 15, 2025
ACCOLADE PLUS TMZF HIP STEM #2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 10, 2011
dS Breast 16ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023