28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CurvaFix IM System
FDA 510(k)
FDA Class 2
·Orthopedic
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376519685·12 mm CORE ENDPLATE, LAT 22 x 25 mm 5°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376520674·16 mm CORE ENDPLATE, LAT 22 x 25 mm 5°
FlexiNylon cartridges Standard Pink
FDA UDI
PERFLEX LTD·07290110500535·box of 6 identical cartridges sealed in aluminu...
Cardiovascular Procedure Kit
FDA UDI
Terumo Cardiovascular Systems Corporation·00699753512986·
FlexiNylon cartridges Standard Pink
FDA UDI
PERFLEX LTD·07290110506476·5 identical cartridges sealed in a vacuum bag ;...
PliaFX Flo
FDA UDI
LIFENET HEALTH·00889858640886·PliaFX Flo Flowable Demineralized Fibers, 5cc
SINGLE USE PRELOADED SPHINCTEROTOME V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
FDA 510(k)
FDA Class 1
·Dental
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·October 9, 2025
RESOLUTION CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·June 17, 2025
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376670447·12mm CORE, NANOTEC LAT 22 x 25 mm 5°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376658223·16mm CORE, NANOTEC LAT 22 x 25mm 5°
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·November 25, 2024
RESOLUTION CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·January 8, 2025
RESOLUTION 360 CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·March 6, 2025
RESOLUTION CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·June 11, 2025
RESOLUTION CLIP
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code PKL·February 13, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025