BEUDAMED
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    VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

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

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169605497·SPACER 2113545 OLIF25 20MM 18 DEG 16X45

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750004546·67 V2 ASSY LARGE 22OD W/HG

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093464·

    SurgyCut

    FDA UDI
    U.S. SURGITECH INC.·00810014632391·SurgyCut J - Wire Foot Control Electrode, 5mm/45cm

    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

    FDA 510(k)
    FDA Class 2 ·Hematology

    BT-350

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    FETAL MONITOR/CARDIOTOCOGRAM

    FDA Adverse Event
    Injury ·BISTOS CO., LTD.·Product code HGL·January 29, 2018

    TRULIANT TIB IMP PS INSERT SZ 4 13MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 10, 2024

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2013

    IMPAX CV OUTBOUND (RESULTS MGMT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    HS BIOBLOC, 19 CM, ST. 14.5 FRENCH, IR

    FDA Adverse Event
    Injury ·C. R. BARD, INC. (BASD)·Product code MSD·June 1, 2011

    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to ultrasonic transducers and ultrasound monitors. Ecolotion is intended to be used externally only as a coupling medium for use in ultrasound procedures.

    FDA Enforcement
    Class I ·Ongoing·AMTEC SALES Inc·September 29, 2021

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021