11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080236170·36mm x 17mm Non-Lordotic Spacer
TREX2/WD06/18/BH16/U2222C/ADULT/U67/1255 9153653553
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·December 23, 2014
NSI HEXED AND NON-HEXED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code LHI·March 27, 2013
FLEXIMA BILIARY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·March 18, 2011
PRECISION XTRA / OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·April 1, 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
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018