BEUDAMED
    33 results · 26ms · Sources: EU EUDAMED, US FDA

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    RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

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

    WhisperPak 7.5cmH2O CPAP Gamida, Case 10

    FDA UDI
    Respironics Novametrix, LLC·00884838075603·

    Bur PM2-70 80K steel Ø2.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055512946·

    Oticon

    FDA UDI
    Oticon A/S·05707131165251·ACPR, ITE VC AP WL L BE ACTO PRO

    BECK DEBAKEY CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921007870·BECK DEBAKEY CLAMP DOUBLE ANGLED JAW

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463570·Endoscopic Kerrison Punch D 4.0mm, 40°, WL 150mm

    PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·September 24, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·September 12, 2014

    EON MINI IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 19, 2011

    UNKNOWN RINGLOC+ REGENEREX CUP

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 28, 2013

    E-POLY 40MM +3 HIWALL LNR SZ24

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MAY·March 28, 2013

    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 24, 2018

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020