BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Arm Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010513762·T-MAX INTUBATION DRAPER BAR

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252236979·LOCKING PLATE,SAGIT. SPLIT,STR,4MM BAR

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133647·LATERAL,FLARED INTERNAL RETRACTOR

    END-TO-END AND SIDE-BY-SIDE CONNECTORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP

    FDA 510(k)
    FDA Unclassified ·Unknown

    PAXGENE® BLOOD DNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·September 14, 2022

    PROFEMUR MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·October 22, 2008

    1064NM ND: YAG LASER

    FDA Adverse Event
    Injury ·CUTERA·Product code GEX·August 10, 2011

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

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

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    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