Device, Communications, Images, Ophthalmic
Radiology · 21 CFR 892.2020
Recent MDR events
39 adverse event reports on file
- OPTOMAP RETINAL SCREENINGMar 12, 2020InjuryUnkMW5093745
- DR-3DTSep 5, 2006MalfunctionInoveon Corporation1651093-2006-00001
- ISCOREApr 25, 2006Malfunction1651093-2006-00008
- ISCOREApr 25, 2006Malfunction1651093-2006-00003
- ISCOREApr 25, 2006Malfunction1651093-2006-00004
- ISCOREApr 25, 2006Malfunction1651093-2006-00007
- ISCOREApr 25, 2006Malfunction1651093-2006-00002
- ISCOREApr 25, 2006Malfunction1651093-2006-00006
- ISCOREApr 25, 2006Malfunction1651093-2006-00005
- DR-3DTApr 25, 2006Malfunction1651093-2006-00012
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
26 firms currently registered for this product code
Optina Diagnostics Inc.
Montreal Quebec, CA
Smith & Nephew Inc.
OKLAHOMA CITY, OK, US
Nidek Co., Ltd. Hamacho Plant
GAMAGORI, AICHI, JP
Nidek Co., Ltd.
GAMAGORI, AICHI, JP
Od-os Gmbh
Teltow Brandenburg, DE
Smith & Nephew Inc.
ANDOVER, MA, US
Carl Zeiss Meditec Ag (jena)
JENA Thuringia, DE
Phoenix Technology Group Llc
Pleasanton, CA, US
Carl Zeiss Meditec Ag (jena)
Jena Thuringia, DE
Nidek Incorporated
The Colony, TX, US
Medimaging Integrated Solution Inc.
Hsinchu Hsinchu (City), TW
Carl Zeiss Meditec Ag (munich)
Muenchen Bavaria, DE
Joslin Diabetes Center
BOSTON, MA, US
Wavelight Gmbh
Teltow Brandenburg, DE
Retivue Llc
Charlottesville, VA, US
Toyo Medical Co.
Doral, FL, US
Fedex Supply Chain, Inc.
Memphis, TN, US
Taishodo Vietnam Co., Ltd.
Dai An Industrial Zone Hai Duong, VN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.