86 results · 37ms · Sources: EU EUDAMED, US FDA

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TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

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

BIOLOK SCREW, BIOSTEON SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS

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

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

ALLEGRETTO WAVE EYE-Q

FDA Adverse Event
Injury ·WAVELIGHT GMBH·Product code LZS·May 1, 2013

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 4, 2014

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 2011

ROUND FILTER POLYPROVPYLENE

FDA Adverse Event
Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

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