7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ARGYLE NASAL CANNULA
FDA 510(k)
FDA Class 1
·Anesthesiology
LIPIFLOW THERMAL PULSATION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TELEFLEX ISIS SUCTION ACCESSORY PACK
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·March 24, 2014
ENEMA BAG
FDA Adverse Event
Injury
·COVIDIEN·Product code FCE·November 7, 2012
PARACHUTE STONE RETRIEVAL BASKET
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FFL·September 14, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021