13 results · 18ms · Sources: EU EUDAMED, 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