13 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERISIL ANTIMICROBIAL TUBING AND BOTTLE
FDA 510(k)
FDA Class 1
·Dental
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MICROPAQ, MODELS 402, 404
FDA 510(k)
FDA Class 2
·Cardiovascular
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code FSA·April 2, 2013
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 24, 2011
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·April 18, 2008
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
WHITE STAR HIGH SPEED VIT CUTTER
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017
SMARTNAIL
FDA Adverse Event
Injury
·CONMED CORPORATION·Product code MAI·July 29, 2019
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021
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