Ophthalmoscope, Battery-powered
Ophthalmic · 21 CFR 886.1570
Recent MDR events
4 adverse event reports on file
- 3 .5V RCHG HANDLE F/DESK CHGRSep 21, 2023MalfunctionWelch Allyn Inc.1316463-2023-00207
- LUMENIS BE INC.Nov 30, 2022MalfunctionLumenis Be Inc3020611964-2022-00004
- PROSCOPE¿ 5210May 20, 2022MalfunctionAmerican Diagnostic Corporation2434008-2022-00001
- WELCH ALLYN OPHTHALMOSCOPE BATTERYApr 22, 2020MalfunctionUnkMW5094241
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
92 firms currently registered for this product code
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
R & D Batteries, Inc.
Burnsville, MN, US
American Diagnostic Corp.
HAUPPAUGE, NY, US
Baxter Healthcare Corporation
ROUND LAKE, IL, US
Armatech International
Sialkot Punjab, PK
Keeler Ltd.
WINDSOR, BERKSHIRE Windsor and Maidenhead, GB
Accutome, Inc.
Malvern, PA, US
Worldwide Supplies Limited
Hong Kong, HK
Medi.plan Gmbh & Co. Kg
Dortmund North Rhine-Westphalia, DE
Sontec Instruments, Inc.
CENTENNIAL, CO, US
Taizhou City K&w International Trade Co.,ltd.
Jiangyan Jiangsu, CN
Toyo Medical Co.
Doral, FL, US
66 Vision Tech Co., Ltd.
Suzhou Jiangsu, CN
Medical Devices (pvt) Ltd.
Sialkot Punjab, PK
Wuxi Zontai Int'l Corporation Ltd.
WUXI Jiangsu, CN
Innovative Innovations Inc.
Henderson, NV, US
Veenak International Limited
BIRMINGHAM, GB
Washington Surgical International
SIALKOT Punjab, PK
Shanghai Canton Optics Equipment Co., Ltd.
Shanghai, CN
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Katmai Health Services Llc
Brilliant, OH, US
510(k) clearances
47 clearances for this product code
- Heine Optotechnik GmbH & Co. KGMay 18, 2015
K142486 · HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
- Heine Optotechnik GmbH & Co. KGJan 29, 2015
K142837 · HEINE SIGMA 250 & HEINE SIGMA 250 M2
- Heine Optotechnik GmbH & Co. KGMar 7, 2014
K131959 · HEINE MINI 3000(R) OPHTHALMOSCOPE
- Heine Optotechnik GmbH & Co. KGDec 4, 2013
K131961 · HEINE BETA 200(R) OPHTHALMOSCOPE
- Medical Devices (Pvt) , Ltd.Oct 30, 2013
K131719 · OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
- Heine Optotechnik GmbH & Co. KGMar 22, 2013
K123587 · HEINE MINI 3000 LED OPHTHALMOSCOPE
- American Diagnostic Corp.Nov 19, 2010
K093495 · OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
- Kirchner & Wilhelm GmbH + Co.KgNov 5, 2007
K070270 · PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36