Camera, Still, Surgical
General, Plastic Surgery · 21 CFR 878.4160
Recent MDR events
22 adverse event reports on file
- XLTEK EEG/PSG DELL OPTIPLEX 5050 SMALL FORM FACTOR SYSTEMMar 20, 2020MalfunctionNatus Medical Incorporated Dba Excel-tech Ltd. (xl9612330-2020-00005
- MOBILE CART CAMERAMar 9, 2020MalfunctionNatus Medical Incorporated9612330-2020-00003
- BRAVOJan 28, 2019MalfunctionGiven Imaging Ltd., Yoqneam9710107-2019-00040
- MENTOR COHESIVE GEL SILICONE BREAST IMPLANTOct 16, 2018InjuryMentorMW5080605
- BRAVOJan 17, 2018MalfunctionGiven Imaging Ltd., Yoqneam9710107-2018-00114
- PILLCAMNov 21, 2017InjuryGiven Imaging Ltd., Yoqneam9710107-2017-05648
- BRAVONov 10, 2017MalfunctionGiven Imaging Ltd., Yoqneam9710107-2017-05610
- BRAVONov 10, 2017MalfunctionGiven Imaging Ltd., Yoqneam9710107-2017-05612
- BRAVONov 10, 2017MalfunctionGiven Imaging Ltd., Yoqneam9710107-2017-05613
- BRAVONov 1, 2017MalfunctionGiven Imaging Ltd., Yoqneam9710107-2017-05598
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
Cook Incorporated
Bloomington, IN, US
M.i.one Co.,ltd.
Wonju-si Gangwon, KR
Altek Medical (kunshan) Limited
Kunshan Free Trade Zone Jiangsu, CN
Altek Biotechnology Corporation
Hsinchu Hsinchu (City), TW
Medimaging Integrated Solution Inc.
Hsinchu Hsinchu (City), TW
Rudolf Riester Gmbh
JUNGINGEN Baden-Wurttemberg, DE
Neko Health Ab
Danderyd Stockholm, SE
Psi Plus Co., Ltd.
Suwon-si Gyeonggi, KR
Canfield Scientific, Inc.
Parsippany, NJ, US
Lumo Imaging Llc
Potomac, MD, US
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi
Cankaya Ankara, TR
Ntl Healthcare Co., Ltd.
Seongnam-si Gyeonggi, KR
Morpheus Co., Ltd.
Yongin Gyeonggi, KR
510(k) clearances
1 clearances for this product code