7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LA ANTIBODY TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
BIOTIS ANAEROBIC KBE AGAR
FDA 510(k)
FDA Class 1
·Microbiology
JAKOBI SURG. INSTRUMENTS #11 11/13/14
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LINOX SMART PROMRI SD 65/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·June 16, 2014
ACTIVE CORD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·December 14, 2012
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 19, 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