13 results
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31ms
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Sources: EU EUDAMED, US FDA
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450221976·
5091470
FDA Adverse Event
Injury
·September 17, 2015
E-Z LINK CROSS CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
SDI SB OFFICE, MODEL 29-
FDA 510(k)
FDA Class 2
·Anesthesiology
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 5, 2016
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·January 27, 2017
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code NBW·December 18, 2016
LCP DIST-TIBPL3.5 ANTERO-LAT R 13HO L184
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·May 3, 2013
SIG MOD TIB TRAY CEM COCR 4
FDA Adverse Event
Injury
·DEPUY IRELAND 9616671·Product code JWH·September 16, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE AND ASSOCIATES, INC.·Product code MIH·May 5, 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
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