21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RAMP NT-PROBNP ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPINE WORKS COLLAR
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PINNACLE PELVIC FLOOR REPAIR KITS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 17, 2013
INFINITI VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 19, 2008
SILVERHAWK® PLAQUE EXCISION SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code MCW·April 20, 2011
ACTIV.A.C. THERAPY
FDA Adverse Event
Injury
·KCI USA INC.·Product code OMP·June 18, 2015
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020
ACTIV.A.C.¿ THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 10, 2020
INFOV.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·March 4, 2021
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·May 22, 2020
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