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

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    SONY LMD-2451MT LCD MONITOR

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

    ASP

    FDA UDI
    SEDATELEC·03760262493428·The ASP Multi, Semi-Permanent Needle, is an ori...

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK113201·DD tempMED are pre-colored dental milling blank...

    Original D Capsules 1 Spill Extra Fast 500 count

    FDA UDI
    Wykle Research, Inc·00853383006103·

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277127471·Ditmars Straight Carpal Tunnel Probe

    NEO / Kinetic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837036478·2mm Kinetic ACP Distractor

    XPERT C. DIFFICLE/EPI ASSAY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MONOMEND MT 3/0 36" (90CM) DS24 (M) VPL

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL SA·Product code GAM·June 13, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

    EXT SET 7IN REM CLAVE SITE NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·May 8, 2013

    MEDICHOICE CAUTERY CORDLESS HIGH TEMPERATURE

    FDA Adverse Event
    OWENS & MINOR, INC.·Product code GEI·August 13, 2008

    GPS PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·May 24, 2011

    SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN ROW

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·December 2, 2025

    Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021