32 results · 20ms · 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.

THE E TEST, MODIFICATION

FDA 510(k)
FDA Class 2 ·Microbiology

MODIFICATION OF NC-STAT

FDA 510(k)
FDA Class 2 ·Neurology

ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

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

BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

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

BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 30, 2016

BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·August 30, 2016

PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES

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

PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES

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

SYNCHROMED

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·November 12, 2010

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 3, 2014

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 21, 2012

BIVONA TTS TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016

BIVONA TTS TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016

BIVONA TTS TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 4, 2016

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 7, 2025

SHOULDER SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·May 5, 2026

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 7, 2016

PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD INC.·Product code JOH·September 7, 2016