10 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
FDA 510(k)
FDA Class 2
·Immunology
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
SOCON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 21, 2022
LARGE HEXAGONAL SCREWDRIVER LONG
FDA Adverse Event
Malfunction
·SYNTHES·Product code HXX·April 29, 2013
FRESENIUS LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 19, 2014
ETS FLEX ARTICNG
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 10, 2011
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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