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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EMIT METHATREXATE ASSAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331146671·cottle septum speculum, self-retaining, side ad...

    A.B. Dental Devices Dental Implants System

    FDA 510(k)
    FDA Class 2 ·Dental

    RANGE SPINAL SYSTEM, LARGE DENALI SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIATHLON CR X3 TIBIAL INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·April 30, 2014

    0.8% SURGISCREEN FOR GEL

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·October 10, 2012

    PORTEX 8.0MM SUCTIONED TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD.·Product code JOH·July 30, 2010

    CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022