23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blueprint Mixed Reality system
FDA 510(k)
FDA Class 2
·Neurology
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376519692·12 mm CORE ENDPLATE, LAT 22 x 25 mm 10°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376520681·16 mm CORE ENDPLATE, LAT 22 x 25 mm 10°
FlexiNylon cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110500580·box of 6 identical cartridges sealed in aluminu...
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113706·PS-C Insert, Size 5 x 10mm
Gold Anchor
FDA UDI
Naslund Medical AB·07340145701060·22G (0.7mm) 25 cm needle with 0.28x10 mm marker
FlexiNylon cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110506520·5 identical cartridges sealed in a vacuum bag ;...
Gold Anchor
FDA UDI
Naslund Medical AB·07340145700964·22G (0.7mm) 25 cm needle with 0.40x10 mm marker
PliaFX Flo
FDA UDI
LIFENET HEALTH·00889858640893·PliaFX Flo Flowable Demineralized Fibers, 10cc
ICRCO 3600M
FDA 510(k)
FDA Class 2
·Radiology
FONIX, MODEL 7000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 27, 2023
Ambassador Cervical Plate System
FDA UDI
Choice Spine, LP·00840996160957·AMBASSADOR,DRILL,2.5x10
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376658230·16mm CORE, NANOTEC LAT 22 x 25mm 10°
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376670454·12mm CORE, NANOTEC LAT 22 x 25 mm 10°
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·February 6, 2019
PILOT DRILL
FDA Adverse Event
Injury
·STRYKER IRELAND LTD.·Product code HTW·November 5, 2008
DILATATION CATHETER, BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LJE·August 25, 2011
COBAS 6000 C501MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 12, 2013