BEUDAMED
    26 results · 33ms · Sources: EU EUDAMED, US FDA

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    ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Klitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

    3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    I-STAT PROTHROMBIN TIME TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIOSURE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code HWC·August 4, 2017

    CUFF STITCH,180 DEG RIGHT

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code NBH·June 26, 2012

    PROFEMUR(R) HIP STEM

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010

    ARTHROPIERCE INSTRUMENT CURVED LEFT

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code NBH·September 2, 2020

    PCH,BSKT,DCKLING,UPBTR

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code NBH·July 19, 2016

    CUFF STITCH 70 DEG RIGHT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code NBH·September 4, 2020

    ARTHROPIERCE 45 DEGREE LEFT

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code HRX·November 15, 2015

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 11, 2013

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER, INC.·Product code MMI·April 15, 2011

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·June 17, 2008

    ARTHRO-PIERCE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code NBH·October 17, 2012

    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013

    HEALICOIL KNOTLESS PK ST

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBI·October 4, 2021

    HEALICOIL KNOTLESS PK ST

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBI·October 4, 2021

    PNCH DUCKLING UPSWEPT W/PRO HNDL

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code NBH·September 1, 2020

    MTO,FERKEL MICROFRACTURE PICK, 90

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code NBH·March 12, 2020