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Cincinnati Sub-Zero Products Inc

20 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The Hemotherm 400CE 115v, containing power board p/n 39945 recall (Z-0654-2017)Cincinnati Sub-Zero Products Inc2016-11-22
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to recall (Z-1129-2015)Cincinnati Sub-Zero Products Inc2015-02-19
115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a pat recall (Z-1679-2014)Cincinnati Sub-Zero Products Inc2014-06-10
Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software i recall (Z-0443-2014)Cincinnati Sub-Zero Products Inc2013-12-04
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road recall (Z-2209-2013)Cincinnati Sub-Zero Products Inc2013-09-16
ECMO Heaters Model 333W, 115V - Part #86135, and 230V & 240V - Part #86136, Cardiopulmonar recall (Z-1656-2012)Cincinnati Sub-Zero Products Inc2012-05-24
Blanketrol II 48C Hyper-Hypothermia System, Model Numbers: 222 and Model Number: 222R. The recall (Z-0969-2012)Cincinnati Sub-Zero Products Inc2012-02-07
Hemotherm 48C Dual Reservoir Heater/Cooler System, Model Number: 400 and Model Number: 400 recall (Z-0970-2012)Cincinnati Sub-Zero Products Inc2012-02-07
Cincinnati Sub Zero, Steri-Probe Temperature Probe, Esophageal/Rectal Temperature Probe, P recall (Z-0372-2012)Cincinnati Sub-Zero Products Inc2012-01-11
Operations and Technical Manuals for the firm's WarmAir Model 135 Hyperthermia System (115 recall (Z-3119-2011)Cincinnati Sub-Zero Products Inc2011-09-01
WarmAir Model 135 Convective Warming Device, Cincinnati Sub-Zero Products, Inc. Used to pr recall (Z-2888-2011)Cincinnati Sub-Zero Products Inc2011-07-27
Model 134, WarmAir Convective Warming Device, 115V, Part #86180, Device Listing #D111865, recall (Z-2800-2011)Cincinnati Sub-Zero Products Inc2011-07-14
ECMO Heater Model 333, Cardiopulmonary bypass temperature controller. This device is inten recall (Z-2720-2011)Cincinnati Sub-Zero Products Inc2011-07-01
ECMO Heater Model 333W, Cardiopulmonary bypass temperature controllers. This device is int recall (Z-2721-2011)Cincinnati Sub-Zero Products Inc2011-07-01
115V Blanketrol III Model 233 Hyper/Hypothermia System, Part number: 86107; and 115V CoolB recall (Z-1817-2011)Cincinnati Sub-Zero Products Inc2011-03-30
FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient recall (Z-0781-2010)Cincinnati Sub-Zero Products Inc2010-02-04
TempPad Cold Therapy Pad. The device is used for localized temperature therapy including h recall (Z-0782-2010)Cincinnati Sub-Zero Products Inc2010-02-04
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in recall (Z-0035-2010)Cincinnati Sub-Zero Products Inc2009-10-29
Electri-Cool II recall (Z-0670-05)Cincinnati Sub-Zero Products Inc2005-04-06
Micro-temp II heat therapy unit, model #747. recall (Z-0671-05)Cincinnati Sub-Zero Products Inc2005-04-06

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Every clearance here is in the API, with alerts when new ones post.