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

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    MODIFICATION TO: INJECTABLE MIMIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    June Medical Galaxy II LUX Connect Surgical Illuminator

    FDA UDI
    Lumitex, Inc.·00812432022471·

    DENALI Spinal System

    FDA UDI
    VB Spine LLC·10888857183339·Offset Hook Holder, Open

    KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP

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

    GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·August 19, 2019

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·August 19, 2019

    UNKNOWN COOL TIP ELECRTRODE

    FDA Adverse Event
    Death ·COVIDIEN MFG DC BOULDER·Product code GEI·August 23, 2019

    UNKNOWN VERSASTEP

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCJ·June 11, 2015

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 29, 2024

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·April 23, 2024

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·December 23, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·March 20, 2013

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    PRESSURE MONITORING SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQO·March 12, 2008

    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

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024