JCAClass II
Device, Bleeding Time
Hematology · 21 CFR 864.6100
MDR events7All time
Recalls1All time
Registered firms4Currently listed
510(k) clearances7All time
Recent MDR events
7 adverse event reports on file
- TENDERFOOT HEEL INCISION DEVICEOct 29, 2014MalfunctionInternational Technidyne Corp.2250033-2014-00007
- TENDERFOOT HEEL INCISION DEVICEJun 26, 2014MalfunctionInternational Technidyne Corp.2250033-2014-00004
- TENDERFOOT HEEL INCISION DEVICENov 12, 2013MalfunctionInternational Technidyne Corp.2250033-2013-00007
- TENDERFOOT DEVICE 1000/CSNov 1, 2011MalfunctionInternational Technidyne Corp.2250033-2011-00028
- TENDERFOOT 50PK DEVICESMar 31, 2011MalfunctionInternational Technidyne Corporation2250033-2011-00007
- TENDERFOOT DEVICES 50/PKMJul 26, 2010MalfunctionInternational Technidyne Corporation2250033-2010-00010
- SIMPLATE IIJul 31, 1992InjuryOrganon Teknita Corporation4182
Event type breakdown
Malfunction6
Injury1
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
4 firms currently registered for this product code
510(k) clearances
7 clearances for this product code
- Organon Teknika Corp.Aug 9, 1991
K911745 · SIMPLATE PEDIATRIC
- International Technidyne Corp.Jul 17, 1991
K911996 · SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
- Helena LaboratoriesJun 10, 1987
K871318 · Q.I.C. BLEEDING TIME DEVICE
- International Technidyne Corp.Mar 1, 1985
K850542 · SURGICUTT - BLEEDING TIME DEVICE
- American DadeMar 17, 1983
K830645 · BLEEDING TIME DEVICE DISPOSABLE
- Ulster Scientific, Inc.Oct 10, 1980
K801815 · AUTOLET
- General DiagnosticsMar 1, 1977
K761250 · SIMPLATE