270 results · 31ms · Sources: EU EUDAMED, US FDA

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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