10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·September 30, 2020
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
OPUS 20, MODEL 1ST
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 2, 2013
MICROSTAAR INJECTOR
FDA Adverse Event
Malfunction
·STAAR SURGICAL CO.·Product code KYB·May 22, 2008
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
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