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

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    REPROCESSED ENDOSCOPIC TROCAR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427514·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427491·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427507·

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 16, 2025

    TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AXILLARY ACCESS ARTERIAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

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

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·February 25, 2021

    FEMOSTOP

    FDA Adverse Event
    Malfunction ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 20, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·February 28, 2011

    GENESIS II

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code HSH·March 12, 2008

    FEMOSTOP

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003

    ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020