BEUDAMED
    21 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MONODERM SURGICAL SUTURE

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814305·GENUMEDI PT SILVER R VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925015722·SCHEER PISTON 4.75 MM OVERALL LENGTH 3.58 MM FU...

    Oticon

    FDA UDI
    Oticon A/S·05707131268952·RIA PRO, DESIGNRITE 10 WL CBE

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704745·Schnidt Hemostatic Forceps 7-1/2" (18.8cm), sli...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776304607·Nail Splitter, 6", straight jaw

    SAS FLUALERT A&B, SAS INFLUENZA A TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    QLAB QUANTIFICATION SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONE TOUCH BASIC ENHANCED

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 7, 2002

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 6, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·June 11, 2014

    COULTER® LH 750 SLIDEMAKER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·June 26, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2013

    CLEO 90 INFUSION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code FPA·August 29, 2008

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 12, 2014

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 18, 2020

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024