8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFEPICO
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BENZODIAZEPINES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MILLENNIUM BLADES, MODEL MB101
FDA 510(k)
FDA Class 1
·Ophthalmic
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 9, 2013
IAB : 8 FR - 30 CC FOS
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·February 24, 2011
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018