BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    TrueCare Biomedix Tamper Evident Cap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERSALOK ORTHOCORD

    FDA UDI
    DEPUY MITEK, LLC·10886705001323·VERSALOK PEEK ANCHOR w/ORTHOCORD PEEK Anchor (1...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180174184·forceps microsurgery, straight, 18cm, tip 0.8mm

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·August 2, 2022

    VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INFANT LIMB HOLDER, MODELS 306080 & 306081

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    INTUITIVE SURGICAL,INC.·Product code NAY·August 12, 2011

    POWERGLIDE 20G, 8CM, BASIC KIT

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS INC.·Product code FOZ·August 1, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    VERSALOK PEEK WITH ORTHOCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·December 28, 2018

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·November 8, 2018

    VERSALOK PEEK WITH ORTHOCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code MAI·May 13, 2019

    Surpria: Software Version V3.11, V3.22

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022

    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

    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