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

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    BIOMESH P1 AND BIOMESH PLUG AND PATCH

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044674·Akers Spoon Only

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964018822·Endo Carry-On Procedure Kit

    GC Fuji Filling™

    FDA UDI
    Gc America Inc.·14548161394314·GC Fuji Filling™ CV, 8 g (3.9 mL) cartridge, mi...

    GC Fuji Filling™

    FDA UDI
    Gc America Inc.·D0470024791·GC Fuji Filling™ CV, 8 g (3.9 mL) cartridge, mi...

    PALCERAM 53

    FDA 510(k)
    FDA Class 2 ·Dental

    MULTI-FUNCTION DEFIBRILLATION ELECTRODE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DA VINCI ROBOTICS SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC.·Product code NAY·October 21, 2003

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·March 13, 2013

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·February 16, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·February 22, 2008

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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