BEUDAMED
    523 results · 18ms · 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.

    ROTATING GAMMA SYSTEM. GAMMA ART-6000

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70603141·Mini-Mono-Brackets Roth 'N' .018" 9° 200 Brackets

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024090·Paddle Shaver, 14mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103140·Shaver, Closed, 14mm

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707003821·Rumor .018 LR4 -17T 0A 0O

    Rumor

    FDA UDI
    Ortho Organizers, Inc.·00190707003838·Rumor .018 LR4 HK -17T 0A 0O

    DIMENSION CTNI CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INCENTIVE SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 11, 2013

    INTERLINK EXTENSION SET W/CONTROL-A-FLO REGULATOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 15, 2011

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 13, 2008

    NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026

    PANEL PHOENIX NMIC-312

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 8, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 15, 2026

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 19, 2026