11 results · 19ms · Sources: EU EUDAMED, 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