236 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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INST 9731132 KIT CR REF FRAME DRIVER 5PK
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·April 24, 2014
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·July 17, 2015
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HAW·August 21, 2015
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
FDA Recall
Terminated
·Elekta Inc·Product code HAW·March 30, 2020
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5
FDA Recall
Terminated
·Invacare Corporation·Product code CAW·October 30, 2020
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
FDA Recall
Terminated
·Caire, Inc.·Product code CAW·March 25, 2022
ROSA Surgical Device 2.5.8
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HAW·February 10, 2013
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HAW·February 5, 2013
ROSA Surgical Device 2.5.8
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code HAW·April 8, 2016
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System, Product Number 66-ZD-MD
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
FDA Recall
Terminated
·FHC, Inc.·Product code HAW·May 10, 2018
PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
FDA Recall
Terminated
·Ethicon, Inc. Us·Product code GAW·May 7, 2018
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·May 10, 2017