8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OXYGEN REGULATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
Artoura Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL SDN BHD·Product code BTR·June 9, 2014
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 8, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·August 21, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024