27 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS
FDA 510(k)
FDA Class 2
·Orthopedic
K090539
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·February 26, 2026
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLS VARUS STEM/CLS 135 STEM
FDA 510(k)
FDA Class 2
·Orthopedic
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 18, 2024
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
BIPAP AUTOSV ADVANCED
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code MNS·January 16, 2023
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 20, 2022
BIPAP AUTOSV ADV SYSTEM ONE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 21, 2022
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·March 12, 2026
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code MNS·October 31, 2022
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 2, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 15, 2014
BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·May 6, 2011
BIPAP AUTOSV ADVANCED SYSTEM
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·January 28, 2022
DREAMSTATION BIPAP AUTOSV
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code MNS·November 1, 2022
BIPAP AUTOSV ADV
FDA Adverse Event
Malfunction
·RESPIRONICS INC·Product code MNS·November 7, 2022