270 results
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31ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
FDA Recall
Open, Classified
·Beijing Syntech Laser Co., Ltd International Industry Base West Area·Product code GEX·July 3, 2017
Soltive SuperPulsed Laser System TFL FIBER CLEAVER, Model Number TFL-AFC
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·December 4, 2023
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·January 29, 2024
Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code GEX·June 30, 2021
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code GEX·May 25, 2023
LCSU 4, Laerdal Compact Suction Unit The LCSU 4 is a portable, electrically powered, medical suction device intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation. Higher vacuum levels are generally selected for oropharyngeal suction, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.
FDA Recall
Terminated
·Laerdal Medical Corporation·Product code JCX·August 31, 2017
Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
FDA Recall
Terminated
·Leoni Fiber Optics GmbH Muhldamm 6 Neuhaus-Schierschnitz Germany·Product code GEX·October 17, 2018
AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code GEX·April 8, 2019
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code GEX·August 13, 2024
Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
FDA Recall
Open, Classified
·Laerdal Medical Corporation·Product code JCX·January 13, 2026