7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
INNOFLUOR PRIMIDONE
FDA 510(k)
FDA Class 1
·Microbiology
NEMECTRODYN MODEL 2 & ENDOVAC 2
FDA 510(k)
FDA Class 2
·Neurology
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·June 25, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 3, 2013
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code INK·November 4, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024