BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker GmbH·00886385005188·Cortical Screw, Self-tap., T6 Drive

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795133885·2.7mm x 12mm, Threaded Peg, Ti

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120120·Screwdriver, Polyaxial, Standard

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033440445·

    THERMO TEK IR FOREHEAD THERMOMETER, MODEL 718F

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES

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

    LIGHT ADJUSTABLE LENS+ (LAL+)

    FDA Adverse Event
    Injury ·RXSIGHT INC.·Product code PZK·June 6, 2025

    C2200M & M2200 LAL SYSTEM/012712

    FDA Adverse Event
    Injury ·STRYKER CORP DBA GAYMAR·Product code FNM·October 24, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 22, 2013

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    PULSE GEN MODEL 101

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 11, 2008

    BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·November 2, 2023

    MAG TPR ADPR TI 38-40/-2 12/14

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·December 13, 2018

    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·November 18, 2015

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018