16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELECTROGLOTTOGRAPH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ReLine
FDA UDI
Nuvasive, Inc.·00195377080660·RELINE C Tap, Ø4.0mm Thoracic
STER TRC 5 XD TF 1.5X4.0MM SCR
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·April 13, 2021
SunTech Medical
FDA UDI
SUNTECH MEDICAL, INC.·10840935110002·
Tiger Sharps Containers
FDA 510(k)
FDA Class 2
·General Hospital
MONTERIS MEDICAL UFO
FDA 510(k)
FDA Class 2
·Neurology
OLYMPUS THUNDERBEAT 5 MM, 35 C M, PISTOL GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·February 7, 2013
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·August 7, 2014
VANGUARD XP TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·October 6, 2017
VANGUARD XP TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·October 6, 2017
VANGUARD XP TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·October 6, 2017
VANGUARD XP TIBIAL TRAY-INTERLOK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·February 22, 2018
VANGUARD XP TIBIAL BEARING-LEFT LATERAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·February 22, 2018
VANGUARD XP TIBIAL BEARING-LEFT MEDIAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OIY·February 22, 2018
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016