12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bonvadis®
FDA 510(k)
FDA Unclassified
·Unknown
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376654331·Straight Spinous Process Clamp, X Large
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251093200·ceraMotion® Ti Gingival 4, 20 g / dental cerami...
OSTEOPORE PCL SCAFFOLD
FDA 510(k)
FDA Class 2
·Neurology
X-CUBE 70, X-CUBE 90
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE 10ML LL S/C 200
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 11, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 9, 2025
24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·August 2, 2017
BARD FLAT MESH
FDA Adverse Event
Injury
·DAVOL INC·Product code FTL·September 13, 2011
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 14, 2014
RESERVOIR 3ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 29, 2013
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024