BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK FIXED PS LINER SIZE 3, 10 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 16, 2014

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 16, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 23, 2017

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 21, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    ETS FLEX ARTICNG LNR CUTR 45MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 13, 2008

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 21, 2017

    INSPIRE 8F DUAL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·January 9, 2026

    INSPIRE 6 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    FDA Adverse Event
    SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 7, 2016

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025