8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIDAS REX III MOTOR
FDA 510(k)
FDA Class 2
·Neurology
Symbia Intevo Bold
FDA 510(k)
FDA Class 2
·Radiology
MINI POWER CHAIR, MODEL MN 5000
FDA 510(k)
FDA Class 2
·Physical Medicine
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
FDA Enforcement
Class II
·Ongoing·Sklar Instruments·January 22, 2025
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 14, 2013
PFC SIGMARP STP TB IN 3 12.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·January 7, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
FDA Recall
Open, Classified
·Sklar Instruments·Product code KAD·December 3, 2024