Refrigerator, Freezer, Blood Storage
Hematology · 21 CFR 864.9700
Recent MDR events
383 adverse event reports on file
- I.SERIESNov 20, 2020MalfunctionHelmer, Inc.10874863
- THERMO SCIENTIFIC AND CARDINAL HEALTHAug 25, 2020MalfunctionThermo Fisher Scientific (asheville) Llc1036832-2020-00001
- REFRIGERATORSep 20, 2019MalfunctionFollett Llc9097504
- I.SERIESJun 27, 2019MalfunctionHelmer, Inc.8739112
- FOLLETT MEDICATION REFRIGERATORJan 25, 2019InjuryFollett LlcMW5083414
- HEMOSAFEAug 5, 2013MalfunctionAngelantoni Life Science Srl1000631067-2013-00001
- HEMOSAFENov 27, 2012DeathAngelantoni Industrie, S.p.a.1000631067-2012-00001
- RED BLOOD CELL FREEZING PACKAug 5, 2010MalfunctionMW5017024
- TAYLOR WHARTON CRYOFREEZERFeb 24, 2010MalfunctionTaylor WhartonMW5014928
- MEDI-FRIDGE MICRO REFRIDGERATORApr 30, 2009InjuryMedi-fridgeMW5010942
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
37 firms currently registered for this product code
Zhongke Meiling Cryogenics Company Limited.
Hefei Anhui, CN
Helmer Inc.
NOBLESVILLE, IN, US
Zhejiang Heli Refrigeration Equipment Co., Ltd.
Jinhua Zhejiang, CN
Infitek Co., Ltd.
Shanghai, CN
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.s.
ANKARA, TR
Qingdao Haier Biomedical Co., Ltd
Qingdao Shandong, CN
P Bhogilal Pvt Ltd
Kolkata West Bengal, IN
Thermogenesis Corp.
RANCHO CORDOVA, CA, US
Mve Cryogenic Biological Equipment (chengdu) Co., Ltd
Pidu District Chengdu Sichuan, CN
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Indrel Scientific
LONDRINA Parana, BR
Marken Healthtech Limited
NASHIK Maharashtra, IN
Lcr Hallcrest, Llc. (il)
GLENVIEW, IL, US
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Vitrafy Laboratory And Manufacturing Centre
Wendouree Victoria, AU
Philipp Kirsch Gmbh
Willstatt Baden-Wurttemberg, DE
Thermo Fisher Scientific (asheville) Llc
ASHEVILLE, NC, US
Scitek Global Co.,ltd
Jinan Shandong, CN
Desmon Spa
Nusco Avellino, IT
Itas G Pharma
Guwahati Assam, IN
Biotecno Industria E Comercio Ltda
SANTA ROSA Rio Grande do Sul, BR
Midea Biomedical Co., Ltd
Hefei Anhui, CN
Horizon Scientific, Inc
Summerville, SC, US
Mark Enterprises
Nashik Maharashtra, IN
510(k) clearances
4 clearances for this product code