ECGClass I
Sterilizer, Boiling Water
Dental · 21 CFR 872.6710
MDR events6All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances7All time
Recent MDR events
6 adverse event reports on file
- HLD SYSTEMSJan 9, 2013MalfunctionCenorin Llc3004153171-2013-00001
- AMSCOAug 17, 1999MalfunctionSteris Canada Corp.9680353-1999-00002
- AMSCONov 11, 1998MalfunctionSteris Canada Corp.9680353-1998-00002
- AMSCOSep 19, 1997MalfunctionHoplab Inc.9680353-1997-00001
- HOPLAB INCNov 7, 1996MalfunctionHoplab Inc.9680353-1996-00001
- AMSCOMATIC WASHER/STERILIZERJul 13, 1992InjuryAmsco/service Company3903
Event type breakdown
Malfunction5
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
7 clearances for this product code
- American Sterilizer Co.Nov 17, 1989
K895164 · EAGLE DS
- Lic-OrthionOct 25, 1984
K843234 · CITOMAT AUTOCLAVES
- Universiti MalayaJun 16, 1981
K811237 · MAGNETIC RETENTION UNIT
- Preat Corp.May 13, 1981
K810977 · ENDODONTIC POST SYSTEMS
- Deringer-Ney, Inc.Apr 10, 1979
K790290 · NEY EQUI-HINGE
- Eurodent, Inc.Feb 27, 1979
K790078 · BAR & RIDER, SCREWS, TUBES
- Amsco Hospital Products Co.Aug 2, 1977
K771266 · STEAM STERILIZER