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

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    Oral/Enteral Syringe with ENFit connector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551110507·HALO, 1203-5 VEST PED0, COOLMAX LINER, 1211-1 X...

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930721102500·Small Elevator 1/4" 5" handle

    Spex

    FDA UDI
    SPEX LIMITED·09420051707306·Spex 2-point hip belt, padded, centre pull with...

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93072110250F0·Small Flat Cobb Elevator 1/4" 5" handle

    Straight Plate, 3.5mm

    FDA UDI
    I.T.S. GmbH·09120034304705·Straight Plate, 3.5mm, 5-Hole

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 25, 2023

    FORTAFLEX SURGICAL MESH

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

    TRIGEN LOW PROFILE BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551053682·SUBDURAL GRID ELECTRODE, PLATINUM, 25 CONTACT, ...

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551053675·SUBDURAL GRID ELECTRODE, PLATINUM, 25 CONTACT, ...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    NOVUM IQ

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2025

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551078241·SUBDURAL GRID ELECTRODE, PLATINUM, 25 CONTACT, ...

    CORTAC®

    FDA UDI
    PMT CORPORATION·00650551078258·SUBDURAL GRID ELECTRODE, PLATINUM, 25 CONTACT, ...

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) NON US

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·October 23, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·August 13, 2011

    OT DELICA LANCING DEVICE

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 8, 2013

    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022

    SINGLE USE GUIDWIRE

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code OCY·August 16, 2022