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

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    Curiteva Sacroiliac Joint Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517628985·CoRoent Ant TLIF Ti, 11x10x40mm 12°

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0104020·Caddie, Large, 30mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0104020·Caddie, Large, 30mm

    Graseby

    FDA UDI
    ICU MEDICAL, INC.·10610586021718·

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857184466·Lordotic Trial, Size 24x30x11 mm, 10°

    SMOOTH-FLO CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BIODESIGN NIPPLE RECONSTRUCTION CYLINDER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDLINE UNITE

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 29, 2014

    TRIPOLE 60-CM PADDLE LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 9, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HTO·April 14, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 13, 2009

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 29, 2021

    Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set. Sterile, non-pyrogenic. Length 105 inch/267 cm, 25 ml priming volume, 20 drops/ml and 1 needless injection site. Manufactured for Deltec SIMS Deltec, Inc., St. Paul, MN 55112 U.S.A. sims Smiths Industries Medical Systems.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 8, 2005

    Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

    FDA Enforcement
    Class II ·Ongoing·FujiFilm Healthcare Americas Corporation·November 10, 2021

    EasyPoint Needle, 25G x 5/8", REF: 82091

    FDA Enforcement
    Class II ·Ongoing·Retractable Technologies, Inc.·March 20, 2024

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Needless Injection site.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022