8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
KOLBERG OPHTHALMIC CONFORMER
FDA 510(k)
FDA Class 2
·Ophthalmic
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105542·KATENA-VANNAS SCISSORS 7MM STRAIGHT
LIATEST(R) AT III TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COBLATOR II (120V)
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·January 31, 2013
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NEK·January 3, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 18, 2014
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