12 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EYE-SYNC
FDA 510(k)
FDA Class 2
·Neurology
UNIVENT TUBE (TCB TYPE)
FDA UDI
FUJI SYSTEMS CORPORATION·04544050056007·ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is i...
UNIVENT TUBE (TCB TYPE)
FDA UDI
FUJI SYSTEMS CORPORATION·04544050123839·ENDOTRACHEAL TUBE, UNIVENT TUBE (TCB Type) is i...
CONSENSUS KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SNARE,FLEXIBLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE GEN MODEL 101
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 17, 2008
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013
3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 24MM
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·April 29, 2015
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021