BEUDAMED
    21 results · 32ms · Sources: EU EUDAMED, US FDA

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    RAHD 3100

    FDA 510(k)
    FDA Class 2 ·Radiology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517961266·Brigade Lateral Trial, 9x34x24mm 10°

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083014063·Fixed, 10 electrode, S, 2-10-2mm electrode spac...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515228757·Elevator "Gimmick",1x12mm tip, ang 15deg, 6 1/2"

    FILAC FAS TEMP ELECTRONIC THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 4, 2024

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code LDF·June 30, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 9, 2013

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 12, 2010

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 4, 2024

    AUTOSOFT 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 4, 2024

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12°

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code KNS·August 11, 2016

    UNKNOWN

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

    IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15 DR/ML,2 CARESITE,146 IN; Catalog Number: 490315. 2. IV ADMN SET,2 CARESITE, SAFEPORT,129 IN.; Catalog Number: 490331. 3. IV ADMIN SET 15 DROPS/ML, CARESITE,98 IN; Catalog Number: 490376.

    FDA Recall
    Open, Classified ·B Braun Medical Inc·Product code FPA·October 29, 2025