15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: GIRAFFE AND PANDA WARMER
FDA 510(k)
FDA Class 2
·General Hospital
Amara View
FDA UDI
Respironics, Inc.·00606959009370·mask cushion
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
FDA 510(k)
FDA Class 2
·Anesthesiology
UNIQUE AMBULATORY EEG
FDA 510(k)
FDA Class 2
·Neurology
TRIMA ACCEL
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·May 2, 2013
GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MAF·September 15, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021
Philips Respironics Amara View Minimal Contact Full-Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
BD TRUCOUNT TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·February 9, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·March 15, 2024
BD MULTITEST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code GKZ·March 15, 2024
BD TRUCOUNT¿ TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 2, 2025