22 results
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75ms
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Sources: EU EUDAMED, US FDA
TRU-PULSE
FDA Adverse Event
Injury
·TISSUE MEDICAL LASERS, INC.·Product code GEX·August 18, 1998
KAMRA CORNEAL INLAY
FDA Adverse Event
Injury
·CORNEAGEN·Product code LQE·October 4, 2018
NIDEK EC-5000 EXCIMER LASER SYSTEM
FDA Adverse Event
Injury
·NIDEK CO. LTD·Product code LZS·May 10, 2010
GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser System, manufactured by American Medical Systems Inc., San Jose, CA The XPS Laser system is indicated for surgical incision and excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
FDA Recall
Terminated
·AMS Innovative Center San Jose·Product code GEX·July 14, 2010
STAR
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code LZS·February 23, 2018
SENSAR IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·May 22, 2026
SENSAR IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·May 22, 2026
TRANSCYTE
FDA Adverse Event
Injury
·ADVANCED TISSUE SCIENCES, INC.·Product code MGR·September 8, 2000
Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA The Fraxel re:store Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
FDA Recall
Terminated
·Solta Medical, Inc.·Product code ONG·December 15, 2010
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
FDA Recall
Open, Classified
·W & H DENTALWERK BUERMOOS GMBH Ignaz Glaser Strase 53 53 IGNAZ-GLASER-STRASSE BUERMOOS Austria·Product code KMW·January 16, 2024
Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-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
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-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
Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-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
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label 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
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
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·TUTOGEN MEDICAL GMBH (TMI)·Product code NPL·August 8, 2025
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·TUTOGEN MEDICAL GMBH (TMI)·Product code NPL·August 8, 2025
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·TUTOGEN MEDICAL GMBH (TMI)·Product code NPL·August 8, 2025
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 Holmium Laser System for fragmentation of urinary calculi and soft tissue applications including incision/excision, ablation, and coagulation
FDA Recall
Terminated
·Cook Inc.·Product code GEX·May 3, 2017
Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration. The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
FDA Recall
Terminated
·Sybaritic, Inc·Product code GEX·April 12, 2008