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

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    U-RIGHT TD-1240 THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ABSOLUTE BI-POLAR SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304003897·

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664005658·FM CASUAL 20-30 KH CT XLFC NA 1 EN FR ES

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104196·Axial Connector Closed

    CARDIO MED MODEL A102, H104, O101, P103, AND Z100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HRH-63-8 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 24, 2020

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·May 15, 2013

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIQ·July 21, 2006

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIQ·July 21, 2006

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

    BIO-MOD BIPOLAR 22.2/+2MM HD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MJT·September 17, 2020

    ABSOLUTE BI-POLAR POLYETHYLENE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·September 17, 2020

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    ACCOLADE DR EL MRI (Model L331)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025