BEUDAMED
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    ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00850268007828·OFFSET STEM IMPACTOR

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014606620·MIDMARK MONTREAL 3.25" SOFTCARE PLUS

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRESSURE TRAK, MODEL 222-B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    LOCKSCR Ø5 SELF-TAP L70 TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HWC·April 26, 2013

    VERSALOK ANCHOR, TI WITHOUT SUTURE

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·April 25, 2011

    APEX PUSH MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·July 22, 2008

    COPELAND THN SHL COCR/HA HUMS3

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWS·August 28, 2025

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·July 17, 2018

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 23, 2025

    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

    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