15 results
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54ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
FDA Recall
Terminated
·Custom Ultrasonics, Inc.·Product code NVE·May 6, 2016
The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.
FDA Enforcement
Class II
·Terminated·Custom Ultrasonics, Inc.·July 13, 2016
83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
FDA Recall
Terminated
·Custom Ultrasonics, Inc.·Product code FEB·December 12, 2005
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA
FDA Recall
Terminated
·Custom Ultrasonics, Inc.·Product code KOG·February 11, 2008
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
FDA Recall
Terminated
·Custom Ultrasonics, Inc.·Product code KOG·March 12, 2013
Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.
FDA Enforcement
Class II
·Terminated·Custom Ultrasonics, Inc.·December 4, 2013
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
FDA Recall
Terminated
·Fujinon Inc·Product code FDS·July 31, 2013
Parks Medical Ultrasonic Doppler Flow Detector with Cautery Suppressor, Model 811-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
Parks Medical Ultrasonic Doppler Flow Detector, Model 811-B (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
FDA Recall
Terminated
·Tenex Health Inc·Product code LFL·April 14, 2014
Parks Medical Dual Frequency Doppler Vascular Flow Detector, Model 915-BL (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007
FDA Recall
Terminated
·Parks Medical Electronics Inc·Product code DPW·November 8, 2007
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Recall
Terminated
·American Optisurgical Inc·Product code LFL·February 22, 2012
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electro cautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electro cautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system is indicated for adult and pediatric use
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·November 11, 2013