FWYClass I
Table, Operating-room, Non-electrical
General, Plastic Surgery · 21 CFR 878.4950
MDR events20All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances4All time
Recent MDR events
20 adverse event reports on file
- HAND CONTROL, OPERATIONG TABLENov 7, 2017Malfunction7006391
- OPERONOct 26, 2012MalfunctionBerchtold Gmbh & Co. Kg8010153-2012-00009
- OPERONOct 26, 2012MalfunctionBerchtold Gmbh & Co. Kg8010153-2012-00010
- OPERONAug 15, 2012MalfunctionBerchtold Gmbh & Co. Kg8010153-2012-00004
- OPERONMar 14, 2012InjuryBerchtold Gmbh & Co. Kg8010153-2012-00001
- OPERONJul 28, 2011MalfunctionBerchtold Gmbh & Co. Kg8010153-2011-00001
- OPERONJul 28, 2011MalfunctionBerchtold Gmbh & Co. Kg8010153-2011-00002
- OPERONMar 3, 2011MalfunctionBerchtold Corp.1220685-2011-00001
- OPERONSep 23, 2010Berchtold Corp1220685-2010-00002
- JACKSON TABLE SYSTEMMay 14, 2008InjuryMizuho Orthopedic Systems, Inc.2921578-2008-00013
Event type breakdown
Malfunction9
Other6
Injury3
Unspecified2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
Ufsk-international Osys Gmbh
REGENSBURG Bavaria, DE
United Poly Engineering Pvt. Ltd.
NEW DELHI, IN
Foshan Ost Medical Equipment Technology Co., Ltd
Foshan Guangdong, CN
Foshan Zubon Technology Co.,ltd.
Foshan City Guangdong, CN
Advanced Instrumentations, Inc.
Miami, FL, US
Foshan Suncare Medical Products Co Ltd
Foshan City Guangdong, CN
510(k) clearances
4 clearances for this product code