BEUDAMED
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    kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening

    FDA 510(k)
    FDA Class 2 ·Radiology

    2.0 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055240·

    Retractor

    FDA UDI
    ELLIQUENCE, LLC·00846338005566·

    LC Instrument Tray

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215076443·

    VERSYS EPOCH FULLCOAT HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP

    FDA 510(k)
    FDA Class 2 ·Radiology

    MOBILELINK ACETABULAR CUP SYSTEM

    FDA Adverse Event
    Malfunction ·WALDEMAR LINK GMBH & CO. KG·Product code LPH·February 20, 2025

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·June 7, 2013

    ELITE MPX

    FDA Adverse Event
    Malfunction ·Product code GEX·October 3, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·June 23, 2011

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·July 26, 2017

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024