18 results
·
72ms
·
Sources: EU EUDAMED, US FDA
HEX HANDLE SUMP SUCKER
FDA Adverse Event
TEXAS MEDICAL PRODUCTS, INC.·Product code DTS·October 9, 1996
BARD - ADULT SUMP SUCKER SURGICAL SUCKER
FDA Adverse Event
Malfunction
·TEXAS MEDICAL PRODUCTS, INC.·Product code DTM·April 17, 1995
BARD/TMP
FDA Adverse Event
Death
·TEXAS MEDICAL PRODUCTS, INC.·Product code DWE·July 1, 1994
PALMAZ GENESIS STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·CARDINAL HEALTH MEXICO·Product code FGE·May 20, 2021
ARCHITECT STAT HIGH SENSITIVE TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD·Product code MMI·January 17, 2020
DALE STABILOCK ENDOTRACHEAL TUBE HOLDER
FDA Adverse Event
Other
·DALE MEDICAL PRODUCTS, INC.·Product code CBH·April 29, 2011
STEP ACCESS DEVICE
FDA Adverse Event
Injury
·INNERDYNE, INC.·Product code GCJ·December 9, 1997
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·July 27, 2023
RING TRANSJUGULAR INTRAHEPATIC LIVER ACCESS AND BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·June 23, 2023
PULSE GEN MODEL 1000
FDA Adverse Event
Malfunction
·LIVANOVA USA, INC.·Product code LYJ·January 25, 2024
670G INSULIN PUMP MMT-1780KL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 28, 2022
Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein Solutions, 901 Yale Street - Houston, Texas 77008, (713) 863-1600 Fax 713 863-1601, www.totalvein.com.
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code DQX·February 26, 2009
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA Recall
Open, Classified
·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JWH·October 27, 2023
VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
FDA Recall
Terminated
·Cyberonics, Inc·Product code LYJ·May 6, 2011
Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
FDA Recall
Terminated
·Cyberonics, Inc·Product code LYJ·May 6, 2011
TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.
FDA Recall
Terminated
·Zimmer Inc.·Product code LXH·October 21, 2010
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices