13 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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C1 RID KIT
FDA 510(k)
FDA Class 2
·Immunology
POINTER F-3 TENS
FDA 510(k)
FDA Class 2
·Neurology
CAVOMAT
FDA 510(k)
FDA Class 2
·Physical Medicine
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES
FDA Adverse Event
Death
·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 12, 2017
PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBES
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD INC.,·Product code JOH·July 16, 2016
BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016
BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·April 27, 2017
ACCU-CHEK ® ADVANTAGE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·January 14, 2013
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Other
·INTEGRA OHIO·Product code HBL·November 18, 2010
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 3, 2014
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024