1,500 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·Micro-Tech Usa·November 25, 2020
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use.
FDA Enforcement
Class III
·Terminated·Celera Corporation·September 4, 2013
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
FDA Enforcement
Class II
·Terminated·Brainlab AG·March 17, 2021
Access BR Monitor, Part No. 387620
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·May 24, 2017
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Brainlab AG·June 16, 2021
OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 M) and KCL (300 M. 10.0ml.) PN: 50003300; Store at d - 15C. Product Usage: General Purpose Reagent for laboratory use.
FDA Recall
Terminated
·Celera Corporation·Product code LDT·July 12, 2013
There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This issue could cause treatment interruption or in a very unlikely scenario, incorrect source positioning and radiation treatment errors.
FDA Recall
Terminated
·Nucletron BV Waardgelder 1 POBox 930 Veenendaal Netherlands·Product code JAQ·November 18, 2019
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
FDA Recall
Terminated
·Micro-Tech Usa·Product code MND·October 5, 2020
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Brainlab AG Olof-palme-str. 9 Munich Germany·Product code IYE·May 14, 2021
Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise direction. The device is a non-adjustable mechanical click style hand torque tool which presents an audible and tactile click when the maximum desired torque is reached.
FDA Enforcement
Class II
·Terminated·Bradshaw Medical Inc.·May 18, 2016
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393. Designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. Intended to be used in a surgical setting.
FDA Recall
Terminated
·Steris Corporation·Product code FTD·February 23, 2010
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
FDA Recall
Terminated
·Gyrus Acmi, Incorporated·Product code ETD·October 17, 2012
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019