13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORMAL AND HYPERGAMMA CONTROL SERUM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BD MICRO FINE ULTRA PRO 4MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·August 19, 2022
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k)
FDA Class 2
·Anesthesiology
CARBODISSECTING ENDOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 30, 2023
CORAIL2 LAT COXA VARA SIZE 10
FDA Adverse Event
Injury
·DEPUY FRANCE SAS ¿ 3003895575·Product code KWA·April 8, 2013
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011
HT50 VENTILATOR
FDA Adverse Event
Malfunction
·FLIGHT MEDICAL LTD.·Product code CBK·April 1, 2008
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018