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

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    ESTECH COBRA BIPOLAR SYSTEM

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

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844818·FOR MEN 20-30 MM HG KNEE HIGH CLOSED TOE SMALL ...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702590036·Elvarex 1/Knee High/Slant-Open Toe/SoftFit/Black

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174088·L Con, Side-Loading, L, 16mm, 100mm

    MetaSystems Probes

    FDA UDI
    MetaSystems Probes GmbH·04251315818187·XL CDKN2A, Deletion Probe

    WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM

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

    PROPOXYPHENE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·May 10, 2018

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    ARCOM 28MM RNGLOC LNR HWALL 23

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 27, 2017

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    PRECISE OTW NITINOL STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIM·May 22, 2008

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 13, 2011

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·February 10, 2025

    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

    FDA Enforcement
    Class II ·Ongoing·Merge Healthcare, Inc.·March 26, 2025