81 results · 24ms · 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.

SELECTIVE RAPID UREA

FDA 510(k)
FDA Class 1 ·Microbiology

VITAL METRICS URINE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BIVONA TRACHEOSTOMY TUBES

FDA 510(k)
FDA Class 2 ·Anesthesiology

PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Death ·SMITHS MEDICAL ASD INC.·Product code JOH·September 19, 2016

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·September 1, 2016

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·April 3, 2018

BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 15, 2016

BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 15, 2016

SYNCHRON® LX® I 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·October 26, 2010

RANT ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·December 21, 2012

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·June 19, 2014

PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

FDA Adverse Event
Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 19, 2017

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

FDA Adverse Event
Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

FDA Adverse Event
Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

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® ADULT TTS¿ TRACHEOSTOMY TUBE

FDA Adverse Event
Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017

PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·July 10, 2017

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

FDA Adverse Event
Death ·SMITHS MEDICAL ASD, INC.·Product code JOH·June 28, 2017