11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO SENTINEL CLIN CHEM CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DCM 2.0
FDA 510(k)
FDA Class 2
·Radiology
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 31, 2024
LID 2/3 LENGTH F/MODULAR GRAPHIC CASE SYSTEM
FDA Adverse Event
Malfunction
·SYNTHES JENNERSVILLE·Product code FSM·April 22, 2013
AUTOCAT2 WAVE
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·August 29, 2014
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 27, 2011
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019
2CM PERIPHERAL CUTTING BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026