BEUDAMED
    21 results · 26ms · Sources: EU EUDAMED, US FDA

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    3M RELY X VENEER CEMENT TRY-IN PASTER

    FDA 510(k)
    FDA Class 2 ·Dental

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103728·BRACKET MEDIUM TWIN MAX RIGHT CENTRAL 022 TQ=+1...

    MEDALLION MODULAR HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304639997·

    V-Loop Variable Loop Catheter Manipulator

    FDA UDI
    Stereotaxis, Inc.·M58800100245210·The Vdrive with V-Loop disposable is indicated ...

    TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

    FDA 510(k)
    FDA Class 2 ·Dental

    SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·November 20, 2018

    CARDIOSAVE HYBRID W/ E/F PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 4, 2025

    2520274-2013-01464

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·March 13, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·January 28, 2011

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·August 12, 2014

    APTIMA SARS-COV-2 ASSAY

    FDA Adverse Event
    Malfunction ·HOLOGIC INCORPORATED·Product code QJR·June 1, 2022

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    OXF ANAT BRG RT MD SIZE 3 PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 9, 2021

    OXF TWIN-PEG CMNTD FEM MD PMA

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·June 9, 2021

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019