BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Amulet™ Steerable Delivery Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776382339·Key Elevator, 1" blade, solid hexagonal handle,...

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813057889·STERILE CARBIDE BUR FG6 DARBY

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780434139·Integra® Jarit® Key Elevator, Solid Steel Handle

    Brevis

    FDA UDI
    BICON, LLC·00813110021878·4.0mm 0° Brevis™ Abutment - 2.5mm Post

    Acute Dual Lumen Hemodialysis Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TEMPOSIL, MODEL 6720

    FDA 510(k)
    FDA Class 2 ·Dental

    GLOBUS

    FDA Adverse Event
    Malfunction ·GLOBUS·Product code HRS·November 24, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 26, 2013

    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures.

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·October 3, 2018

    Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018

    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013