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

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    ACL TOP Family 70 Series

    FDA 510(k)
    FDA Class 2 ·Hematology

    Unity Total Knee System

    FDA UDI
    CORIN LTD·05056139232978·Unity ASC Femoral PS Saw Resection Guide Std

    Intrigue

    FDA UDI
    LANCER ORTHODONTICS, INC.·00817573020959·INTRG WHISP ROTH BIC HK-7T 0A 018 UR

    TSI

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215004552·

    NRFit® Caps, Male and Female Neuraxial Tip Caps

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CMD 23-1031 HUMERAL IMPLANT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code JDC·July 24, 2023

    TEMA ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·January 24, 2025

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code MMI·May 8, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·October 30, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 19, 2011

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 12, 2013

    BD¿ STEM CELL ENUMERATION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·December 12, 2023

    greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003

    FDA Enforcement
    Class II ·Completed·Greiner Bio-One North America, Inc.·May 24, 2023

    Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

    FDA Enforcement
    Class I ·Terminated·TELEFLEX MEDICAL INC·February 23, 2022

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023

    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

    FDA Enforcement
    Class II ·Ongoing·Carl Zeiss Meditec AG·May 4, 2022

    Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 8, 2023

    Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020