BEUDAMED
    24 results · 22ms · Sources: EU EUDAMED, US FDA

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    3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S

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

    K121116

    FDA UDI
    Life Spine, Inc.·00190837016029·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016043·

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837016258·

    UHEAD

    FDA UDI
    Stryker GmbH·00886385013718·Awl Assembly

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383543972·Gutta Percha Points is used to root canal filin...

    BD MAX¿ VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·March 16, 2026

    BD MAX¿ VAGINAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·March 16, 2026

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 30, 2002

    HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CODA BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQY·April 4, 2019

    VIDAS® LYME IGG

    FDA Adverse Event
    Injury ·BIOMERIEUX, S.A.·Product code LSR·December 8, 2016

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·June 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 11, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Injury ·BIOENTERICS CORPORATION·Product code LTI·September 18, 2008

    VIDAS® FT4

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code CEC·March 15, 2017

    VIDAS® FT4

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code CEC·February 20, 2017