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

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    Blue Sky Bio TAD

    FDA 510(k)
    FDA Class 2 ·Dental

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446914068·SPECIAL, ARG PERIPHERAL GUIDE REPLACEMENT THUMB...

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112366·CHUCK HANDLE #3K 10CM LONG

    Conventional Lead Apron .5mm Large 24 X 42

    FDA UDI
    Flow X Ray Corporation·00843696123437·Conventional Lead Apron .5mm Large 24 X 42, Gray

    WAKO AUTOKIT LP(A)/DADE DEMENSION

    FDA 510(k)
    FDA Class 2 ·Immunology

    SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05, SCS CLARIS SPINAL SYSTEM,EXTENDED OMNIAXIALO

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 2, 2013

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

    INSPIRE OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·October 20, 2014

    VASOVIEW 7 XS

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 5, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 2, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 27, 2019

    CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·May 17, 2017

    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·February 21, 2018

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024