561 results
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76ms
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Sources: EU EUDAMED, US FDA
EPIC¿ VALVE (AORTIC)
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code LWR·June 27, 2023
EPIC¿ VALVE (AORTIC)
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code LWR·June 27, 2023
COULTER FC500 FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·November 15, 2011
UNKNOWN STAR MOBILE BEARING
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·April 18, 2019
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 15, 2011
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
American Medical Systems, Inc., (AMS) GreenLight HPS Fiber Optic (ADDStat) Part Number 0010-2090B. Fiber optic laser for treatment of BPH (Benign Prostatic Hyperplasia). AMS Innovative Center, San Jose, CA 95134
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·June 18, 2007
UNKNOWN STAR POLYETHYLENE COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR POLYETHYLENE COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TALAR COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TALAR COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TALAR COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·July 14, 2020
UNKNOWN STAR TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·August 10, 2020
UNKNOWN MOBILE BEARING
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·February 18, 2020
UNKNOWN TALAR COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code NTG·February 18, 2020
UNKNOWN TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER GMBH·Product code JWH·February 18, 2020
Allez Medical Applications, Inc. 4Closure Surgical Fascia Closure System , Catalog ref. 4S. Sterile, One Time Use, Contents 4 sets 1- suture passer instrument. Distributed by Aliez Medical Applications, Inc., Santa Ana, CA 92707. Synovis over labels the "Distributed by....", For Customer Service Contact: Synovis Surgical Innovations 2575 University Ave W., St. Paul, MN 55114-1024
FDA Recall
Terminated
·Synovis Surgical Inovation Div. of·Product code GDF·June 19, 2007