BEUDAMED
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    V12 PRO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DYONICS / HELICUT

    FDA UDI
    Smith & Nephew, Inc.·00885554012712·BURR 4.5 HELICUT LG MOUTH DSPL DYO PWR

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·November 17, 2020

    VYGON SPLIT CANNULA INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY

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

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·November 17, 2020

    VIDAS SARS-COV-2 IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QKO·December 30, 2020

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 18, 2019

    Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·July 20, 2022

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NKM·October 29, 2014

    EASYTRAK 2

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NIK·July 8, 2013

    CS3 BED 9153651161

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·November 9, 2015

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020