609 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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BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
FDA Enforcement
Class II
·Terminated·Flexicare Medical Ltd.·January 22, 2020
BRILLIANCE 16 AIR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·April 28, 2015
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·June 24, 2014
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX·Product code OGH·May 5, 2014
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·July 1, 2015
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·July 1, 2015
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·August 19, 2015
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·September 14, 2015
LAYRNG-O-JET KIT
FDA Adverse Event
Injury
·Product code OGH·June 21, 2021
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX·Product code OGH·March 10, 2014
RUSCH RI FIBER-OPTIC LARYNGOSCOPE KIT
FDA Adverse Event
Malfunction
·TELEFLEX·Product code OGH·October 16, 2014
KIT: CIRCUMCISION 20/CS
FDA Adverse Event
Injury
·MEDICAL ACTION INDUSTRIES·Product code OGH·May 18, 2026
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX·Product code OGH·April 14, 2014
KING VISION VIDEO LARYNGOSCOPE
FDA Adverse Event
Injury
·AMBU / KING SYSTEMS·Product code OGH·August 15, 2018
LARYNGOSCOPE ADAPTER
FDA Adverse Event
Injury
·AMBUUSA / KING SYSTEMS CORPORATION·Product code OGH·February 11, 2020
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·March 27, 2015
RUSCH MRI COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OGH·March 20, 2015
KING VISION
FDA Adverse Event
Injury
·KING SYSTEMS (AMBU)·Product code OGH·April 1, 2016
RUSCH MIR COND FIBER OPTIC LARYN KIT
FDA Adverse Event
Malfunction
·Product code OGH·January 26, 2015