67 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient sling apparatus. The scale is not intended to be used for patient transport.
FDA Enforcement
Class II
·Terminated·Sr Instruments Inc·April 24, 2013
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Recall
Terminated
·STEP-HAR MEDICAL LLC·Product code FRN·February 26, 2021
Walcott Rx Products, Surgical Division, Corneal Marking Pad, REF RX40490, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
Aspen Surgical, Corneal Marking Pad, Gentian Violet Ink, REF 40490, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010
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
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
Maximum Pelvic Trainer (MPT)
FDA Recall
Terminated
·Ralston Group·Product code HIR·July 12, 2019
Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
FDA Recall
Terminated
·Teleflex Medical·Product code BSR·December 2, 2011
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·March 13, 2015
Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.
FDA Recall
Terminated
·Aspen Surgical Products, Inc.·Product code HMR·December 23, 2010