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Spacelabs Healthcare, Llc

24 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Updat recall (Z-1273-2014)Spacelabs Healthcare, Llc2014-03-25
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended f recall (Z-0871-2014)Spacelabs Healthcare, Llc2014-01-30
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor wi recall (Z-0351-2014)Spacelabs Healthcare, Llc2013-11-18
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patie recall (Z-0188-2014)Spacelabs Healthcare, Llc2013-11-08
Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys recall (Z-0694-2013)Spacelabs Healthcare, Llc2013-01-17
qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm a recall (Z-0403-2013)Spacelabs Healthcare, Llc2012-11-20
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor ( recall (Z-0196-2013)Spacelabs Healthcare, Llc2012-11-05
Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound v recall (Z-2382-2012)Spacelabs Healthcare, Llc2012-09-14
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It i recall (Z-2019-2012)Spacelabs Healthcare, Llc2012-07-16
The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthca recall (Z-1831-2012)Spacelabs Healthcare, Llc2012-06-20
Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon Bedsi recall (Z-1705-2012)Spacelabs Healthcare, Llc2012-06-05
Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter recall (Z-0776-2012)Spacelabs Healthcare, Llc2012-01-17
Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for us recall (Z-0690-2012)Spacelabs Healthcare, Llc2012-01-11
Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with t recall (Z-3036-2011)Spacelabs Healthcare, Llc2011-08-18
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Dete recall (Z-3032-2011)Spacelabs Healthcare, Llc2011-08-17
Spacelabs Medical elance Vital Signs Monitor, Model 93300. The Spacelabs elance Vital Sign recall (Z-3024-2011)Spacelabs Healthcare, Llc2011-08-15
Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient mo recall (Z-2916-2011)Spacelabs Healthcare, Llc2011-08-02
Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14. Spacelabs Healthcare recall (Z-2902-2011)Spacelabs Healthcare, Llc2011-08-01
Pathfinder Holter Analyzer is a Programmable Diagnostic Computer. The brochure is labeled recall (Z-2611-2011)Spacelabs Healthcare, Llc2011-06-22
The Ultraview SL 91517 Capnography module is a mainstream and sidestream gas analyzer desi recall (Z-2573-2011)Spacelabs Healthcare, Llc2011-06-20
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470 recall (Z-2134-2011)Spacelabs Healthcare, Llc2011-05-03
Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capabili recall (Z-0813-2011)Spacelabs Healthcare, Llc2010-12-27
Spacelabs Medical Flat Panel Display is a touchscreen display, 19-inch thin film transisto recall (Z-0620-2011)Spacelabs Healthcare, Llc2010-12-14
BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge recall (Z-2113-2010)Spacelabs Healthcare, Llc2010-07-29

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