137 results
·
87ms
·
Sources: EU EUDAMED, US FDA
PROTOUCH LATEX EXAMINATION GLOVES
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL PRODUCTS, INC.·Product code LYY·November 4, 1994
BIOTOUCH LATEX EXAM GLOVES
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL PRODUCTS, INC.·Product code LYY·August 23, 1994
XEN 45 GTS
FDA Adverse Event
Injury
·ALLERGAN (IRVINE)·Product code KYF·February 1, 2019
AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN
FDA Recall
Terminated
·American Medical Systems·Product code FAE·February 19, 2007
AMS 800
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·June 25, 2018
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·April 15, 2025
OPTIFLUX DIALYZER
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·April 30, 2015
AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
FDA Recall
Terminated
·American Medical Systems·Product code FAE·February 19, 2007
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Injury
·OPTONOL, LTD·Product code KYF·February 24, 2011
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Injury
·OPTONOL, LTD.·Product code KYF·February 24, 2011
HYALURONIC ACID
FDA Adverse Event
Injury
·FIDIA FARMACEUTICI S.P.A.·Product code MOZ·February 5, 2018
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Injury
·OPTONOL, LTD.·Product code KYF·February 24, 2011
NATURALYTE BICARBONATE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 30, 2015
HEP-LOCK
FDA Adverse Event
WYETH-AYERST LABORATORIES·Product code FMF·February 28, 2002
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC·Product code OTN·February 12, 2013
NATURALYTE 2251 2K 2.5CA
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 30, 2015
GENERAL SURGERY TRAY
FDA Adverse Event
Malfunction
·OWENS & MINOR DISTRIBUTION, INC.·Product code LRO·April 7, 2025
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·May 4, 2016
COVIDIEN NEEDLELESS MED PREP CANNULAS
FDA Adverse Event
Malfunction
·CARDINAL HEALTH, INC.·Product code GEA·March 3, 2025
18G HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·MEDLINE INDUSTRIES, INC.·Product code OES·March 3, 2025