57 results
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32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYLAB40
FDA 510(k)
FDA Class 2
·Radiology
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 8, 2021
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 11, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·June 20, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·May 25, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 19, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 21, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·July 11, 2022
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 22, 2013
ENCORE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·April 27, 2011
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·June 30, 2008
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Other
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·May 11, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·August 2, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·May 27, 2022
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 12, 2023