47 results
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13ms
·
Sources: EU EUDAMED, US FDA
Software version 4.44A utilized on the BD MAX System
FDA Recall
Terminated
·BD LIFE SCIENCES·Product code NSX·July 29, 2015
MEDTRONIC CARELINK 2090 programmer
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·January 17, 2019
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·January 17, 2019
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·January 17, 2019
Merlin PCS programmer (Model # 3650), Software (Model # 3330)
FDA Recall
Terminated
·St Jude Medical Inc.·Product code OSR·April 16, 2018
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.
FDA Recall
Terminated
·St Jude Medical Inc.·Product code OSR·August 28, 2017
8F ZUMA 2 SR 4.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40SH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 3.5 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35SH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 5.0 SH 100CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50SH
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 4.0 100CM CATHETER Z28SR40 Z2 8F 100CM SR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR40
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR30
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 5.0 100CM CATHETER Z28SR50 Z2 8F 100CM SR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR50
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
8F ZUMA 2 SR 3.5 100CM CATHETER Z28SR35 Z2 8F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z28SR35
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·December 17, 2012
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
FDA Recall
Terminated
·Mizuho OSI·Product code FWZ·March 28, 2017
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
FDA Recall
Terminated
·Mizuho OSI·Product code GDC·December 14, 2015
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·October 14, 2019
Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
FDA Recall
Terminated
·Nellcor Puritan Bennett·Product code BSR·July 12, 2006
Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
FDA Recall
Terminated
·Teleflex Medical·Product code BSR·August 24, 2015