20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FIBERGRAFT BG Matrix Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
LuxaPrint Ortho Flex 385
FDA UDI
DMG Digital Enterprises SE·D9821712840·(Meth) acrylate-based light-curing resin for th...
MODEL SEGAEGO 3D SCOOTER
FDA 510(k)
FDA Class 2
·Physical Medicine
FACET SCREW SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
OPTICROSS HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025
ACCU-CHEK D-TRONPLUS
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·August 25, 2009
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·October 14, 2014
MEDTRONIC
FDA Adverse Event
Malfunction
·Product code LGW·July 18, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013
ECHELON ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2019
OPTICROSS? HD
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026