11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SAVI Dual (TM) Migraine Therapy
FDA 510(k)
FDA Class 2
·Neurology
EarQ
FDA UDI
Sbo Hearing A/S·05714464029402·EARQ F50 MINIRITE T C091
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula
FDA 510(k)
FDA Class 2
·Cardiovascular
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 29, 2021
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·November 7, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 1, 2011
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·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