10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G
FDA 510(k)
FDA Class 2
·General Hospital
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·March 17, 2021
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REGAIN DESKTOP
FDA 510(k)
FDA Class 2
·Neurology
WALLFLEX¿ BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 23, 2013
MAIH, 2.0 DIA, W/SWITCH, 100-120V ONLY
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 25, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·May 8, 2013
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·August 8, 2012
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