Light, Examination, Medical, Battery Powered
General Hospital · 21 CFR 880.6350
Recent MDR events
10 adverse event reports on file
- VEINLITE NEOJul 5, 2023MalfunctionTranslite Llc17253932
- EYEMAG LIGHT IIFeb 7, 2022MalfunctionCarl Zeiss Meditec Ag (oberkochen)9615010-2022-00001
- EYEMAG LIGHT IISep 20, 2018InjuryCarl Zeiss Meditec Ag (oberkochen)9615010-2018-00013
- LUMADENTJul 15, 2016OtherUnkMW5063463
- FLX-LITE, STERILE, SINGLE USE, FLEXIBLE SURGICALDec 3, 2015Conmed Linvatec1017294-2015-00067
- VEINLITEMar 16, 2012OtherTranslite LlcMW5024703
- OUTPATIENT II DOUBLE CEILINGMay 2, 2006MalfunctionBurton Medical Products2018492-2006-00007
- OCU-FILMAug 17, 2005MalfunctionMedtronic Ophthalmics: A Division Of Medtronic Xomed, Inc.633959
- BURTONFeb 5, 2003MalfunctionBurton Medical Products Inc443437
- FIELD SURGICAL LIGHTJul 17, 2000MalfunctionGetinge/castle, Inc.MW1019298
Event type breakdown
Registered firms
159 firms currently registered for this product code
Modern Medical Equipment Manufacturing, Ltd.
KWAI CHUNG, N.T., HK
Wuxi Allied Technologies, Inc.
Wuxi Jiangsu, CN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Fedex Supply Chain, Inc.
Memphis, TN, US
Easy-rn, Llc
Coral Springs, FL, US
Nanjing Yameng Intelligent Technology Co., Ltd
Nanjing Jiangsu, CN
Millennium Surgical Corp
Schaumburg, IL, US
Long Island Technology Group Llc
Farmingdale, NY, US
American Diagnostic Corp.
HAUPPAUGE, NY, US
M&s Technologies
NILES, IL, US
Zumax Medical Co, Ltd.
SUZHOU,JIANGSU, CN
Ultralight Optics Inc.
Westminster, CA, US
Jenius Medical Sci-tech (thailand) Co., Ltd.
Nong Yai District, Chon Buri, TH
Dentlight Inc.
Plano, TX, US
Ecleris Srl
Villa Martelli Buenos Aires, AR
Prestige Medical
Grand Prairie, TX, US
Medical Illumination International, Inc
Chatsworth, CA, US
Sugih Instrumendo Abadi, Pt
Bandung Barat Jawa Barat, ID
Ningbo Ningyuan Import & Export Co., Ltd.
NINGBO, ZHEJIANG, CN
Rz Medizintechnik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Chin Kou Medical Instrument Co.,ltd.
NEW TAIPEI CITY, TW
United Poly Engineering Pvt. Ltd.
NEW DELHI, IN
Kentron Health Care, Inc.
SPRINGFIELD, TN, US
Ningbo Greetmed Medical Instruments Co., Ltd.
Ningbo Zhejiang, CN
Mdf Instruments Medifriend Inc.
SONG JIANG DISTRICT, SHANGHAI, CN
510(k) clearances
6 clearances for this product code
- Olympic Medical Corp.Mar 27, 1992
K920782 · OLYMPIC TRANS-LITE
- Suncoast Medical Manufacturers, Inc.May 22, 1984
K841588 · SUN-LITE WHITE SPOT
- Suncoast Medical Manufacturers, Inc.May 22, 1984
K841589 · C-LITE
- Concept, Inc.Jun 22, 1979
K791001 · PENLIGHT/SWAB HOLDER
- Abco Dealers, Inc.Sep 7, 1978
K781228 · PENLIGHTS
- Taylor Instrument Analytics Co.Jan 26, 1977
K760972 · TYCOS DIAGNOSTIC PENLIGHT