BEUDAMED
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    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM

    Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112588·BARRON CORNEAL PUNCH 6.75MM

    LORENZ RESORBABLE DISTRACTOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER

    FDA 510(k)
    FDA Class 2 ·Immunology

    PERMANENT PACEMAKER ELECTRODE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DTB·August 12, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

    UNKNOWN EEA

    FDA Adverse Event
    Injury ·US SURGICAL PUERTO RICO·Product code GDW·June 3, 2020

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 22, 2015

    ALINITY C CREATININE

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code CGX·June 22, 2020

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUEROT RICO OPERAITONS CO.·Product code MHY·October 16, 2008

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC·Product code NBW·June 27, 2013

    UNSPECIFIED SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 5, 2011

    Y-90 THERASPHERE

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·June 22, 2023

    BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 8, 2023

    BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·August 12, 2024

    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021