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Spacelabs Healthcare, Incorporated

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The recall (Z-3185-2011)Spacelabs Healthcare, Incorporated2011-09-12
The product is a 19" Spacelabs Medical Flat Panel Display, Model 94260-19, manufactured by recall (Z-0288-2011)Spacelabs Healthcare, Incorporated2010-11-02
Intesys Clinical Suite (ICS) G2 92810 Smart Disclosure. The Smart Disclosure product colle recall (Z-2270-2010)Spacelabs Healthcare, Incorporated2010-08-25
Spacelabs Model 91367 SL 2200 Compact Monitor Spacelabs Medical patient monitors passively recall (Z-0647-2010)Spacelabs Healthcare, Incorporated2010-01-19
Spacelabs Model 91369-24 SL 2400 Compact Monitor Spacelabs Medical patient monitors passiv recall (Z-0648-2010)Spacelabs Healthcare, Incorporated2010-01-19
Spacelabs Model 91370 SL 2600 Compact Monitor Spacelabs Medical patient monitors passively recall (Z-0649-2010)Spacelabs Healthcare, Incorporated2010-01-19
Spacelabs Medical Integrated ECG Cable are supplied as part of the start-up kits provided recall (Z-2211-2009)Spacelabs Healthcare, Incorporated2009-09-11
Ultraview Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital Tele recall (Z-2336-2008)Spacelabs Healthcare, Incorporated2008-09-25
Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear pl recall (Z-2314-2008)Spacelabs Healthcare, Incorporated2008-09-20
Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient recall (Z-2342-2008)Spacelabs Healthcare, Incorporated2008-09-19
Ultraview SL Command Module, Model 91496 The product is intended for use with the Patient recall (Z-2343-2008)Spacelabs Healthcare, Incorporated2008-09-19
Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemet recall (Z-1652-2008)Spacelabs Healthcare, Incorporated2008-09-18
Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaqua recall (Z-0660-2008)Spacelabs Healthcare, Incorporated2008-01-31
Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor. recall (Z-0523-2007)Spacelabs Healthcare, Incorporated2007-02-27

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