BEUDAMED
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    LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010064912·4.0MM PARTIALLY THREADED ...

    Cup Forceps

    FDA UDI
    ELLIQUENCE, LLC·00846338003692·

    VTS1000

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INQU PASTE MIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    DA VINCI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL·Product code NAY·May 15, 2013

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code OAD·September 26, 2014

    COULTER LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 20, 2011

    UNK BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·Product code JXG·December 6, 2017

    UNK BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·Product code JXG·December 6, 2017

    UNK BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·Product code JXG·December 6, 2017

    UNK BACTISEAL EVD CATHETER

    FDA Adverse Event
    Injury ·Product code JXG·December 6, 2017

    NEUROPEN NEUROENDOSCOPES

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code GWG·August 8, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025