11 results
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31ms
·
Sources: EU EUDAMED, US FDA
OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
K2-HF ENAMEL opal orange, EIO-OR, 50g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38624020·
EASYSTAND EVOLV
FDA 510(k)
FDA Class 2
·Physical Medicine
4CIS® Marlin ACIF Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
REVEAL XT
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code DSI·June 10, 2014
CAPTURE-R READY SCREEN 3
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·October 8, 2010
ILS 29MM, CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 10, 2012
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·March 30, 2026
MEDTRONIC ICD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·March 30, 2026
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
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