11 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PlaDuo System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Atellica CH Enzymatic Creatinine_3 (ECre3)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MECTALIF ANT - LAG
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024
1.85MM TI MATRIX SCREW SELF-DRILLING/4MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code JEY·March 6, 2017
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 14, 2008
PINNACLE MTL INS NEUT36IDX62OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011
PARIETEX UGYTEX PP 15X10CM X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·July 8, 2013
30K FSI-PWR-FG-100 INSERT,PKD
FDA Adverse Event
Malfunction
·DENTSPLY LLC·Product code ELC·November 20, 2024
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·April 25, 2011
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025