BEUDAMED
    73 results · 20ms · Sources: EU EUDAMED, US FDA

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    TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Polishers

    FDA UDI
    DFS - DIAMON GmbH·04057176161475·2metal polisher cup CA 6p

    MGB Alert HSV 1&2 Typer Probe Mix ASR - 48 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951572·MGB Alert® HSV 1 & 2 Probe Mix is an analyte sp...

    AcQMap

    FDA UDI
    ACUTUS MEDICAL, INC.·00857042007005·North America Power Cord

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551201374·VOLKAMNN Retractor, 6 prongs

    0800,APS0,08,N,VL,TB,RW

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828153058·0800,APS0,08,N,VL,TB,RW

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209101054·KIT, BELT TRAUMA - BASIC

    MAESTRO WRIST FRACTURE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIP- VARIABLE INTENSITY POLYMERIZER

    FDA 510(k)
    FDA Class 2 ·Dental

    BIODESIGN 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INCORPORATED·Product code FTM·April 3, 2014

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·October 22, 2012

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·September 18, 2023

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·November 14, 2023

    Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT200007; 5) BT-20-0007; 6) BT200011; 7) BT-20-0011; 8) RMS010118CP.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·April 7, 2025

    Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·April 7, 2025

    Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code CBK·May 29, 2024

    9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.

    FDA Recall
    Terminated ·Cardiac Science Corporation N7·Product code MKJ·January 14, 2016

    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization

    FDA Recall
    Terminated ·Cenorin, LLC·Product code LDS·April 9, 2018

    Automated External Defibrillator (non-wearable). Model number 9200, 9200N, 9200DN, 9200RD, 9210N, 9210RD, and CardioVive 92530. The battery component is warranted for 5 years, and electrodes have a shelf life of 2 years. The Powerheart AED G2 and CardioVive 92530 are intended to acquire the ECG rhythm for the detection of, and to provide treatment for, ventricular tachyarrhythmias of patients who are at risk of sudden cardiac arrest. The device is intended to be used in medically supervised environments by trained personnel, in which patients are under the direct care of physicians and/or medical persons authorized by the state, province, or country regulations in which they practice.

    FDA Recall
    Terminated ·Cardiac Science Corporation·Product code MKJ·June 29, 2011