5 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Sonesta S2; Article numbers: 525-S2-110V and 525¿¿S2-220V
FDA Enforcement
Class II
·Terminated·Sonesta Medical Ab·May 10, 2017
Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System, Catalog/Model Numbers: 8200010, 8200TWA0
FDA Recall
Terminated
·Boston Scientific·Product code DRF·February 18, 2005
SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe.
FDA Recall
Terminated
·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code DXN·December 31, 2009
SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe.
FDA Recall
Terminated
·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code DQA·December 31, 2009
SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe.
FDA Recall
Terminated
·Mindray DS USA, Inc., dba Datascope Patient Monitoring·Product code DQA·December 31, 2009