25 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Athena Surgical RMUS System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOBUTTON
FDA UDI
Smith & Nephew, Inc.·03596010497031·55 MM ENDOBUTTON CL BTB
Dilator, Vascular, Memory 20cm 5.0mm alu-handle
FDA UDI
Geister Medizintechnik GmbH·04057034308554·Dilator, Vascular, Memory
20cm 5...
Salvo® Spine System
FDA UDI
Spine Wave, Inc.·10840642174892·10.5 x 70 mm Bone Screw, Cannulated, 3 mm Pitch
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319706367·Kleinert-Kutz Hook 6-1/4" (15.6cm), large size,...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319744321·Kleinert-Kutz Hook 5" (12.7cm), large size, 7mm...
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP
FDA 510(k)
FDA Class 2
·Neurology
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 19, 2024
CONTOUR® PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 16, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 5, 2025
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
CONTOUR® NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 2, 2025
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Other
·DEXCOM, INC.·Product code MDS·August 2, 2011
MONARCH II IOL DELIVERY SYSTEM CARTRIDGE - B
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code KYB·October 22, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 8, 2013
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 29, 2022