Source, Carrier, Fiberoptic Light
Ear, Nose, Throat · 21 CFR 874.4350
Recent MDR events
36 adverse event reports on file
- FAN SPRAY KITMay 4, 2026MalfunctionZimmer Surgical, Inc.0001526350-2026-00531
- KARL STORZ LIGHT CABLE 3.5MM X 300CM 495 NDJan 26, 2026MalfunctionKarl Storz Se & Co Kg.MW5182801
- LIGHT GUIDE COMPATIBLE WITH DAVINCI 5Oct 30, 2024InjurySchoelly Fiberoptic, GmbhMW5161961
- STORZ ILLUM, 3.5MM X 8' PILLING INSTRMay 22, 2024MalfunctionTeleflex Medical3011137372-2024-00082
- RELIEVA LUMA LIGHT GUIDE CABLE 2Oct 25, 2022InjuryAcclarent, Inc.3005172759-2022-00024
- .197 IN X 10FT (5MM X 3.05M) AUTOCLAVABLE LIGHT GUIDENov 8, 2021InjuryFiberoptics Technology Inc1017294-2021-00355
- LIGHT GUIDE UNIVERSALMar 14, 2019MalfunctionFiberoptics Technology Inc1320894-2019-00070
- RUSCH GREEN LITEMar 9, 2017InjuryTeleflexMW5068401
- 0 OBSOLETE, USE 00-LX300-TSYS-13Feb 8, 2017MalfunctionIntegra York, Pa Inc.2523190-2017-00008
- LUXTECJan 10, 2017MalfunctionIntegra Lifesciences Corporation6236525
Event type breakdown
Registered firms
103 firms currently registered for this product code
Arthrex New Zealand Limited
Auckland, NZ
Arthrex, Inc.
Naples, FL, US
Phoenix Instruments, Inc.
Lisle, IL, US
Med2b Ltd.
Kitzingen Bavaria, DE
Beijing Fanxing Guangdian Medical Treatment Equipment Co Ltd
BEIJING, CN
Arthrex, Inc.
Ave Maria, FL, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Acclarent, Inc.
Irvine, CA, US
Intuitive Surgical, Inc.
Santa Clara, CA, US
Inka Surgical Instruments
Jandakot Western Australia, AU
Symmetry Surgical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
American Medical Endoscopy
Doral, FL, US
Black & Black Surgical, Inc.
Tucker, GA, US
Shenzhen Shanglaite Electronic Technology Co. Ltd
Shenzhen Guangdong, CN
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Olympus Medical Systems Corp.
HACHIOJI-SHI Tokyo, JP
Mattes Instrumente Gmbh
Tuttlingen-Nendingen Baden-Wurttemberg, DE
Fentexmedical Gmbh
NEUHAUSEN, BW Baden-Wurttemberg, DE
Stryker Endoscopy
SAN JOSE, CA, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Arthrex Manufacturing Inc.
Pendleton, SC, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Aizu Olympus Co., Ltd.
AIZUWAKAMATSU-SHI Fukushima, JP
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Fiberoptics Technology, Inc.
Pomfret, CT, US
510(k) clearances
49 clearances for this product code
- Wells Johnson Co.Dec 4, 1995
K945876 · WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT
- Jedmed Instrument Co.Nov 13, 1995
K954184 · JED-LIGHT FIBEROPTIC LIGHT SOURCE
- Laser-Optik-Systeme GmbH & Co. KGJul 10, 1995
K951829 · COLD LIGHT SOURCE LOS 150
- Xomed-Treace, Inc.Aug 24, 1994
K932771 · BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE
- Gm Engineering, Inc.Aug 23, 1994
K941661 · GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT
- Gm Engineering, Inc.Jul 20, 1994
K941662 · GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT
- San Diego Swiss Machining, Inc.Jun 21, 1994
K934911 · SAPHIRE PLUS SURGICAL MIRROR
- Medical Instrument Development Laboratories, Inc.Apr 1, 1994
K932131 · MID LABS TWIN ILLUMINATOR