8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOYA IS INJECTOR SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
FDA 510(k)
FDA Class 2
·Cardiovascular
READYSWIM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MCLAUGHLIN +5 ACETABULAR SHELL 60MMX23L
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·April 26, 2013
DUROM US ACETABULAR COMPONENT 52/46 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·April 28, 2011
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·July 24, 2008
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
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018