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