11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CUDA SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MOR® Implant 3.0 X 13mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108259·The MOR is a self-tapping, small diameter, scre...
HERO VASCULAR ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICKIE 2 POWER ASSIST WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
AMS MINIARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS·Product code PAH·June 30, 2014
BIVONA CUSTOM 3.0 FLEXTEND TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SIMTHS MEDICAL ASD, INC.·Product code JOH·November 9, 2010
HUDSON MICRO MIST NEBULIZER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·January 3, 2013
FT3 - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·October 10, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·September 30, 2016
Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
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