18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·December 14, 2016
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Orthos
FDA UDI
ORMCO CORPORATION·00889989053401·L6R SL B/T ORTHOS 22 FLG -22/0/0
Symmetry Deschamps
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482054918·Symmetry® Ligature, Desch, Sharp Right, 8 in
ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F
FDA 510(k)
FDA Class 2
·Cardiovascular
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 20, 2017
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·August 1, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·July 25, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·August 17, 2017
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·March 21, 2017
HUDSON SILENT HUMIDIFIER ADAPTOR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·May 23, 2013
VECTORVISION NAVIGATION SW SPINE (VERS. 5.6.0)
FDA Adverse Event
BRAINLAB AG·Product code HAW·September 12, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN·Product code CBK·June 26, 2017
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018