BEUDAMED
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    GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777518·LUMBAMED PLUS FLEX PAD M SILVER IV

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885554012354·MEDIA DVD-R PANASONIC LM-RF120U

    Anti-Jka (JK1)

    FDA UDI
    DIAGAST·23661562105346·Blood Grouping Reagent, Anti-Jka (Human/Murine ...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180107359·5 MM DIA., 45 CM INSULATED SLING ELECTRODE, SID...

    RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CROSS-CHECKS DUAL, MODEL CI 125

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    RF3000 RADIOFREQUENCY GENERATOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SAN JOSE·Product code GEI·October 29, 2014

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 10, 2011

    PROMOTE PLUS CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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