10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS IGG REAGENT
FDA 510(k)
FDA Class 2
·Immunology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 27, 2023
OPUS ROD FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CEMENTED CALCAR HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 29, 2024
OMNIGUIDE BEAMPATH FIBER AND ADAPTER
FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·April 23, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 1, 2011
CURRENT VR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 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