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

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SONOLITH I-SYS LITHOTRIPER

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

TROJAN CRYSTAL CLEAR LIQUID

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2025

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

NON AC-POWERED PATIENT LIFT

FDA Adverse Event
Malfunction ·UNKNOWN·Product code FSA·April 29, 2013

ATTAIN OTW

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 10, 2011

CELL-DYN WBC REAGENT A

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·July 29, 2008

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