4 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·December 30, 2008
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012