11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aspirex Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
EarQ
FDA UDI
Sbo Hearing A/S·05714464029389·EARQ F50 MINIRITE T C090
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDO ARIA
FDA 510(k)
FDA Class 2
·Radiology
TYCO HEALTHCARE KENDALL
FDA Adverse Event
Injury
·TYCO HEALTHCARE GROUP LP·Product code FMI·January 24, 2015
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 7, 2008
PINN MAR NEUT 32IDX56OD
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·September 1, 2011
2520274-2013-04475
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·July 16, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025