15 results
·
24ms
·
Sources: EU EUDAMED, US FDA
YASARGIL PERMANENT ANEURYSM CLIPS
FDA 510(k)
FDA Class 2
·Neurology
ACTICOAT 7 DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GLUCANPRO
FDA 510(k)
FDA Unclassified
·Unknown
EGIA ULTRA UNIVERSAL SHORT STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SUR·Product code GDW·April 18, 2012
ENDO GIA ROTICULATOR* 60-3.5 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·October 10, 2014
IDRIVE ULTRA POWERED HANDLE 1
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·September 19, 2016
ENDO GIA* II 45-2.5 DLU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAG·October 9, 2014
ENDO GIA ROTICULATOR* 60-4.8 SULU
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·November 25, 2014
INTER-LOCK SCREWDRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·February 28, 2013
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORP.·Product code LZG·February 20, 2011
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·February 19, 2008
EGIA 45 ARTICULATING MED/THICK SULU
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·December 9, 2015
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021