BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    Tenex 2nd Generation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101223·ELLIS FOREIGN BODY SPUD

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04059993292813·ELVAREX 2/CHAP STYLE/SLANT-OPEN TOE/SLIP FORM W...

    PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LOGIC CR FEMORAL POR, LEFT, SZ 3

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 8, 2024

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    G7 NEUTRAL ARCOMXL LNR 32MM G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·June 18, 2019

    G7 PPS LTD ACET SHELL 58G

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·June 18, 2019

    32MM MOD HEAD COCR -3MM NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 18, 2019

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014