Light, Surgical, Instrument
General, Plastic Surgery · 21 CFR 878.4580
Recent MDR events
10 adverse event reports on file
- ILED7 SURGICAL LIGHTAug 26, 2025InjuryBaxter Healthcare Corporation3007143268-2025-00069
- ILED 7 SURGICAL LIGHTSMar 13, 2025InjuryBaxter Medical Systems Gmbh + Co. KgMW5167645
- LIGHT SOURCEApr 27, 2023Malfunction16822681
- ILED7Nov 20, 2018MalfunctionTrumpf Medizin Systeme Gmbh + Co. Kg9681407-2018-00069
- TRULIGHT DUOAug 16, 2018MalfunctionTrumpf Medizin Systeme Gmbh + Co. Kg9681407-2018-00039
- ILED-7Dec 21, 2017InjuryTrumpf Medical SystemsMW5074185
- KNIFE LIGHT 10/PKJun 3, 2013MalfunctionStryker Osteosynthesis-freiburg0008010177-2013-00107
- KNIFE LIGHT 10/PKMay 8, 2013MalfunctionStryker Osteosynthesis-freiburg0008010177-2013-00017
- PALOMAR MEDILUXOct 5, 2004InjuryPalomar Medical TechnologiesMW1033394
- SATIN SLIPSep 29, 2004MalfunctionRespiratory2936999-2004-00033
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
28 firms currently registered for this product code
Arch Medical Solutions - Seabrook
SEABROOK, NH, US
Xenosys Co., Ltd.
Incheon, KR
Shenzhen Yinghuada Technology Co.,ltd
Shenzhen Guangdong, CN
Viant As&o Holdings, Llc
Brimfield, MA, US
Baxter Medical Systems Gmbh + Co. Kg
SAALFELD Thuringia, DE
Etkin Tibbi Cihazlar San. Ve Tic. A.s.
Cigli Izmir, TR
Neo Medical S.a.
Villette (Lavaux) Vaud, CH
Alira Medical Devices Llc
Rancho Cucamonga, CA, US
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Precision Optics Corp.
GARDNER, MA, US
Shenzhen Shanglaite Electronic Technology Co. Ltd
Shenzhen Guangdong, CN
Baxter Medical Systems Gmbh + Co. Kg
Munich Bavaria, DE
Micropulse Inc
Columbia City, IN, US
International Sterilization Laboratory, Llc
GROVELAND, FL, US
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Viseon, Inc.
Irvine, CA, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Shandong Chenhong Medical Technology Co., Ltd.
JINING CITY Shandong, CN
Depuy Spine, Inc.
RAYNHAM, MA, US
Neo Spine Usa Inc.
Hackensack, NJ, US
Zhejiang Fude Medphotonic Co.,ltd.
Huzhou City Zhejiang, CN
Gyrus Acmi, Inc.
BARTLETT, TN, US
Dongguan Kaiser Technology Co., Ltd
Dongguan city Guangdong, CN
Swan Medical Sl
Barcelona, ES
Qufu Lekang Medical Technology Group Co.,ltd.
JINING CITY Shandong, CN
510(k) clearances
7 clearances for this product code
- Aaron Medical IndustriesJul 30, 1993
K932139 · LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT
- Midmark Corp.Jul 30, 1993
K930686 · MIDMARK SURGICAL LIGHTING SYSTEMS
- Alm Surgical Equipment, Inc.Jan 12, 1993
K922409 · ALM ILLUMINATOR SERIES LIGHT SYSTEM
- Alm Surgical Equipment, Inc.Oct 1, 1992
K921848 · BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT
- Medical Products Development, Inc.Feb 26, 1981
K803067 · SURG-FLEX 10 LIGHT
- Medical Products Development, Inc.Jan 23, 1981
K810019 · SURG-FLEX 15 SURGICAL LIGHT
- Medical Products Development, Inc.Jan 23, 1981
K810018 · SURG-FLEX 5 SURGICAL LIGHT