BEUDAMED
    18 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.

    TauTona Pneumoperitoneum Assist Device (TPAD)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM

    EM

    FDA UDI
    Allied Medical, LLC·00026072022405·SELECTOR VALVE

    TSI Stem Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040574·

    devemed

    FDA UDI
    devemed GmbH·04061644033003·Vascular tweezers "De Bakey" ATRAUMA, 1.6 mm | ...

    Spectral CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMPAK ACRYLIC REPAIR RESIN LIQUID

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·June 21, 2015

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·May 29, 2025

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    OLYMPUS EVIS EXERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code FDT·July 19, 2011

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 18, 2013

    VITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·June 21, 2017

    VITEK 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards per carton.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code N/A·April 20, 2017

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·May 28, 2025

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024