30 results
·
56ms
·
Sources: EU EUDAMED, US FDA
INFINITY TALAR DOME SZ 2 TOTAL ANKLE SYSTEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·March 9, 2026
BD PYXIS¿ MEDSTATION¿ ES AUXILIARY
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·May 5, 2025
BD PYXIS¿ MEDSTATION¿ ES
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code BRY·May 2, 2025
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 16, 2014
ADVIA CENTAUR XP VITAMIN D TOTAL (VITD) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MRG·December 7, 2016
FLORIDA MEDICAL DEVELOPMENT LITHOTRIPTOR
FDA Adverse Event
Injury
·Product code FFK·January 11, 2010
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device. This device is used in cannulation of the ductal system and for sphincterotomy.
FDA Recall
Terminated
·Cook Endoscopy·Product code KNS·October 30, 2008
HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code MPN·September 2, 2016
INTELLIVUE MP20
FDA Adverse Event
Malfunction
·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·January 5, 2025
FARAWAVE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code QZI·September 26, 2025
POLARX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC DE COSTA RICA S.R.L.·Product code OAE·September 26, 2025
PREMILENE 5/0 (1) 45CM DS12 (M) POW
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAW·April 12, 2017
IN.PACT ADMIRAL
FDA Adverse Event
Injury
·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·March 6, 2015
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
FDA Adverse Event
Injury
·INVATEC TECHNOLOGY CENTER GMBH·Product code ONU·March 6, 2015
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS NORTH AMERICA LLC·Product code MHX·September 21, 2021
ViewPoint; system, imaging processing, radiological
FDA Recall
Open, Classified
·GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany·Product code LLZ·August 8, 2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Recall
Open, Classified
·GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany·Product code LLZ·August 8, 2024
Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection, storage, and clinical information management with independent bedside devices and ancillary systems that are connected either directly or through networks. The eCareManager system provides patient information and surveillance of monitored patients at the point of care location and at a remote, supplementary care location through wide area networking technology and dedicated phone lines and is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
FDA Recall
Terminated
·Visicu, Inc.·Product code MSX·February 22, 2012
GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by Cardiac Science Corporation, Automated External Defibrillator
FDA Recall
Terminated
·Cardiac Science Corporation·Product code MKJ·October 13, 2008
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
FDA Recall
Open, Classified
·X-NAV Technologies, LLC·Product code QRY·March 4, 2024