11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
Entuit Thrive LP
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00827002356627·
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 26, 2021
STOCKERT COMPACT SYSTEM VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ET III SA FIXTURE SYSTEM
FDA Adverse Event
Injury
·HIOSSEN INC.·Product code DZE·April 4, 2013
31G X 8MM BD PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON·Product code FMI·March 30, 2011
VITALITY DS VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012
STERRAD® NX STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018
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