BEUDAMED
    18 results · 28ms · 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.
    Filters Regulation: Us FDA ×

    VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772826353·LUMBAMED SACRO, GREY, IV

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481111006·LOCATOR R-Tx Abutment for 4.3mm Camlog Connecti...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114618·LOCATOR F-Tx Abutment for 4.3mm CAMLOG Connecti...

    ITOTAL OVAL PATELLA TRIAL 38MM

    FDA UDI
    Conformis, Inc.·00810933030438·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450181164·

    STRYKER NAVIGATION SYSTEM-KNEE MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    WIN-1 TANGO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 29, 2026

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    ATLAS II VR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2011

    CRYSTALENS

    FDA Adverse Event
    Injury ·EYEONICS, INC.·Product code HQL·July 22, 2008

    Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OJA·June 11, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018