BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124771·Modular Stem 13mm x 125mm

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053982·ACCENT B/T 5SGL F/S NDX -27TX18 LL

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132611·IN-OVATION® C Roncone 022 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100132101·IN-OVATION® C Base Rx 022 U3-3 CS HK

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·July 11, 2005

    MUSE CARDIOLOGY INFORMATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEURO II-S

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOUBLE MOBILITY HC LINER 28/DMM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 5, 2016

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    ITST FEMORAL NAIL

    FDA Adverse Event
    Injury ·ZIMMER·Product code JDS·May 30, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·August 29, 2008

    OPTITORQUE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·Product code DQO·January 20, 2021

    The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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