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Sources: EU EUDAMED, US FDA
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AR ManoShield, MSS-3599, 10 pack. FGS: MSS-3599, Individual package label: LBL-110275-03, Box label: LBL-110282-03, Package Inserts: DOC-3682, User Manual: DOC-1332-12. Product Usage: The MVS disposable sheath (a.k.a. ManoShield) for the high-resolution MVS catheter is designed to provide a biocompatible barrier between the catheter and patient.
FDA Recall
Terminated
·Sierra Scientific Instruments Inc·Product code FFX·October 12, 2011
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
FDA Recall
Terminated
·Philips North America, LLC·Product code OWB·April 10, 2020
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
FDA Recall
Terminated
·Philips North America, LLC·Product code OWB·April 10, 2020
Bausch & Lomb Millenium Phacoemulsification Needles, Needle Frag 15 Degree, REF MVS 1600A, 6 needles per pouch, nonsterile.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code NKX·March 26, 2008
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 20, 2020
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·May 20, 2020
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
FDA Recall
Terminated
·Medtronic Navigation, Inc.-Littleton·Product code OWB·September 17, 2018
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !DOV BI70000027100 BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R BASE OARM 8170000027120 SYSTEM 120V 8170000027120 BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R BASE OARM Bl70000027230 SYSTEM 230V 8170000027230 BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR BASE OARM 8170000028100 SYS lOOV 8170000028100 BASE OARM BI70000028120 SYS 120V 8170000028120 BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R BASE OARM BI70000028230 SYS 230V BI70000028230 BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R Product Usage: The 0-arrn Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
FDA Recall
Terminated
·Medtronic Navigation, Inc.-Littleton·Product code OXO·May 1, 2019
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.
FDA Recall
Terminated
·Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt·Product code KGX·February 21, 2011
PremierPro Aluminum Adjustable Walker
FDA Enforcement
Class II
·Terminated·SVS LLC·November 28, 2018
ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018
Theratron Elite 80 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Phoenix Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 780C Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron Elite 100 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000E Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
Theratron 1000 Cobalt Radiotherapy
FDA Recall
Terminated
·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004
BVS 5000t Bi-Ventricular Support System Transport/Backup Console Catalog Number: 0050-000
FDA Recall
Terminated
·Abiomed, Inc.·Product code DSQ·August 19, 2003