16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Synaptive ImageDrive Pro
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517566492·CoRoent Ant TLIF PEEK, 15x13x28mm 4°
LAMINOPLASY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MAGBODY DT-600
FDA 510(k)
FDA Class 2
·Neurology
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 11, 2025
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
MEMBRAGEL
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code NPK·June 30, 2011
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FKX·September 8, 2008
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·April 22, 2020
SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017
SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017
SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017
SCR BIORCI 7X25MM (8MM HEAD) STRL BX 1
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC.·Product code HWC·August 17, 2017
Allura Xper FD20/15; System Code: 722058;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025