9 results
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25ms
·
Sources: EU EUDAMED, US FDA
ANOLIFT - PORTABLE & ANOLIFT - GANTRY
FDA 510(k)
FDA Class 1
·General Hospital
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051822·.022 L6R STD/NC 0T 5 OFF
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
FDA 510(k)
FDA Class 2
·Dental
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT
FDA 510(k)
FDA Class 2
·Orthopedic
UNSPECIFIED SAFESET TRANSPAC SETS
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025
AGILITY HYDROPHILIC STEERABLE GUIDEWIRES
FDA Adverse Event
Malfunction
·CORDIS NEUROVASCULAR, INC.·Product code DQX·June 30, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·January 8, 2013
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 10, 2010
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