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

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    BIOSTAR OIA SHIGATOX

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ULTRA -THIN SDS BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)

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

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·December 8, 2006

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 16, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 18, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·June 16, 2008

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·August 12, 2025

    CERENOVUS ENTERPRISE

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·August 26, 2025

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024