13 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ICAN COTTON RAYON BALLS

FDA 510(k)
FDA Class 1 ·General Hospital

24M - RJ Corman - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588140810·24M - RJ Corman - Metal

MRCAT Head & Neck

FDA 510(k)
FDA Class 2 ·Radiology

AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES

FDA 510(k)
FDA Class 2 ·Radiology

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

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·January 14, 2013

CRTICAL BONE SCR 30MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HWC·December 1, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014