Timer, General Laboratory
Clinical Chemistry · 21 CFR 862.2050
Recent MDR events
7 adverse event reports on file
- UNIPLATE ACP LARGE BONE SCREW, 5.20X14MMMay 22, 2006InjuryDepuy Spine, Inc.1526439-2006-00112
- CD HORIZON SPINAL SYSTEMApr 20, 2006InjuryWarsaw Orthopedic Inc1030489-2006-00107
- CD HORIZON SPINAL SYSTEMAug 24, 2005InjuryWarsaw Orthopedic Inc.1030489-2005-00250
- CD HORIZON SPINAL SYSTEMJun 15, 2005InjuryWarsaw Orthopedic Inc.1030489-2005-00172
- CD HORIZON SPINAL SYSTEMMay 18, 2005MalfunctionWarsaw Orthopedic Inc.1030489-2005-00134
- CD HORIZON SPINAL SYSTEMMay 18, 2005MalfunctionWarsaw Orthopedic Inc.1030489-2005-00132
- SPINE SYSTEMAug 12, 1996InjuryJbs, Sa2916714-1996-00003
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- O-Two Medical Technologies, Inc.TerminatedJun 22, 2017
O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 ---
Malfunction of an O-Two Adult Ventilation Timer, where the flash rate of the malfunctioning device was reported to be twice that of the rate noted on the label.
Z-2705-2017 · View FDA record ↗ - Nova Biomedical CorporationTerminatedJan 17, 2008
Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples
Z-0295-2008 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Diatrust Medical Co., Ltd.
Nanjing City Jiangsu, CN
Qingdao Unison Industries Co., Limited
SHANDONG, CN
Hospital Equipment Mfg. Co.
NOIDA Uttar Pradesh, IN
Sysmex Ra Co., Ltd, Main Office
Shiojiri Nagano, JP
Zepf Medical Instruments Gmbh
SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE
Time Timer Llc
Cincinnati, OH, US
Dimeda Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
O-two Medical Technologies, Inc.
Brampton Ontario, CA
Ningbo Ningyuan Import & Export Co., Ltd.
NINGBO, ZHEJIANG, CN
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Accuster Technologies Pvt. Ltd.
NEW DELHI, IN
Ningbo Castle Medical Import & Export Co.,ltd
Ningbo Zhejiang, CN
Sysmex Corporation Techno Park
KOBE Hyogo, JP
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.