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

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    ATLANTIS ABUTMENT FOR ZIMMER INTERFACE

    FDA 510(k)
    FDA Class 2 ·Dental

    PROCAD ADD-ON

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNI C ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEMICAP/UNICAP RESURFACING PROSTHESIS

    FDA Adverse Event
    Other ·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012

    QUILL SRS

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 17, 2009

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code NEW·May 12, 2009

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·April 11, 2013

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·August 27, 2014

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·December 26, 2012

    Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·February 24, 2016

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025