BEUDAMED
    19 results · 20ms · 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 ×

    UNIMAX ANTI-FOG SOLUTION

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

    Bone cutters

    FDA UDI
    DFS - DIAMON GmbH·04057176147998·Bone Cutter type 162 HP

    Bernafon

    FDA UDI
    Bernafon AG·05711584004838·CT9 CP, VC PS GB CANTEO 9

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026278·microSelectron Transfer Tube for 5F Flexibles (26)

    StaXx® XD System

    FDA UDI
    Spine Wave, Inc.·10840642100747·Cartridge Convex Expandable Implant 22x9x15mm

    Biopsy Forceps

    FDA UDI
    ENDO-THERAPEUTICS, INC.·00816207020754·Endoscopic Biopsy Forceps

    Biopsy Forceps

    FDA UDI
    ENDO-THERAPEUTICS, INC.·00816207020792·Endoscopic Biopsy Forceps

    ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·March 9, 2020

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 6, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 2, 2011

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LQC·August 13, 2008

    COBAS 6000 E601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 10, 2025

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS NORTH AMERICA LLC·Product code MKJ·December 13, 2023

    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

    FDA Enforcement
    Class III ·Terminated·Diagnostica Stago, Inc.·September 24, 2014

    MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025