BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    OXOID PYLORI TEST KIT, MODEL DR0130M

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040132913·Zirlux TR A2 98x14mm

    HI-TORQUE CONNECT

    FDA UDI
    ABBOTT VASCULAR INC.·08717648174988·Hi-Torque Connect Guide Wire .018" 195 cm

    DOCKERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427798·

    DOCKERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427804·

    DOCKERS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427811·

    SURETONE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECSYSCA 15-3 II ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular, Inc.·January 1, 2014

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 18, 2008

    VERITAS

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FTM·April 6, 2020

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 20, 2013

    ASR ACETABULAR CUPS 56

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

    SAGB QUICKCLOSE WITH VELOCITY INJECTION PORT

    FDA Adverse Event
    Injury ·OBTECH MEDICAL SARL·Product code LTI·March 12, 2008

    LEG BAG WITH FLIP-FLO¿ VALVE

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code FAQ·May 15, 2024

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    FDA Recall
    Terminated ·Abbott Vascular, Inc.·Product code DQX·November 25, 2013

    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

    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