8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
E.R.C.P. CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
QUALTEX SURGICAL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
FDA 510(k)
FDA Class 2
·Radiology
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPP·January 14, 2013
QUANTUM 2000
FDA Adverse Event
Other
·COOPERSURGICAL·Product code GEI·November 24, 2010
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·July 3, 2014
ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·January 8, 2014
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