8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
EYE SPOT IM TEST
FDA 510(k)
FDA Class 2
·Immunology
SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ
FDA 510(k)
FDA Class 1
·Clinical Toxicology
COLONOSIGHT MODEL 510B
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
PERFORMANCE PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 29, 2013
DASH PORT II
FDA Adverse Event
Malfunction
·GENERAL ELECTRIC·Product code MHX·December 14, 2010
1020279-2014-00416
FDA Adverse Event
SMITH & NEPHEW, INC.·Product code JWH·July 14, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024