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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REFLECTION, TANDEM UNIPOLAR
FDA 510(k)
FDA Class 2
·Orthopedic
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292794·
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215021504·
E-Z EM PERCUPUMP 2001 CT INJECTOR
FDA 510(k)
FDA Class 2
·Radiology
VERSABOND BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GTY·January 13, 2026
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 8, 2013
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·April 27, 2011
GE OEC 2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 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