KQSClass I
Table, Cystometric, Non-electric And Accessories
Gastroenterology, Urology · 21 CFR 876.4890
MDR events638All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances8All time
Recent MDR events
638 adverse event reports on file
- CYSTO TABLEAug 19, 2022MalfunctionDornier Medtech Systems GmbhMW5111624
- DORNIER MEDTECH OPUS IINov 6, 2020MalfunctionDornier Medtech Systems GmbhMW5097707
- DMT CYSTO TABLEJul 24, 2020MalfunctionDornier Genesis / Dornier Medtech Systems GmbhMW5095725
- DORNIER OPUS IIDec 22, 2016Dornier Medtech Systems Gmbh1037955-2016-00046
- HYDRA VISIONNov 6, 2014MalfunctionLiebel-flarsheim Company Llc4252773
- DORNIER LITHOTRIPTER SIINov 15, 2013InjuryDornier Medtech Systems, Gmbh1037955-2013-00022
- HUT EXT DR FINAL ASSY-REVERSESep 4, 2013MalfunctionLiebel-flarsheim Company1518293-2013-00206
- DORNIER RELAX + TABLENov 6, 2012MalfunctionDornier Medtech Systems Gmbh1037955-2012-00024
- HUT EXT DR FINAL ASSY-STANDARDFeb 28, 2012MalfunctionLiebel-flarsheim Co.1518293-2012-00029
- HUT EXT DR FINAL ASSY-REVERSEFeb 28, 2012MalfunctionLiebel-flarsheim Co1518293-2012-00041
Event type breakdown
Malfunction624
Other6
Injury5
Unspecified3
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
510(k) clearances
8 clearances for this product code
- Dornier Medtech America, Inc.Dec 6, 1995
K955019 · UROTRACT I
- Oec-Diasonics, Inc.Jul 16, 1987
K872022 · UROVIEW
- American Sterilizer Co.Dec 24, 1986
K864846 · RADIOGRAPHIC - LEG SECTION
- Mallinckrodt Group, Inc.Feb 10, 1986
K860040 · HYDRAJUST III UROLOGICAL TABLE
- American Sterilizer Co.Aug 8, 1985
K852127 · AMSCO URO-ENDO MOBILE TABLE
- Siemens Corp.Aug 13, 1980
K801723 · UR 150-UR 150T
- Sybron Corp.Oct 22, 1979
K791699 · HYDRADJUST II UROLOGICAL TABLE
- Mallinckrodt Group, Inc.Dec 16, 1976
K760522 · TABLE, UROSURGICAL