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

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    LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Site-Rite

    FDA UDI
    Bard Access Systems, Inc.·00801741037849·21G NG Kit with 96in Probe Cover (10PK)

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002196·artVeneer life upper posteriors, S, BL4

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159018332·Vascular Clamp with 25 mm Hausmann Jaw

    P7-3Ts Ultrasonic Probe(FDA/Refurbished)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088150·

    JEL BIOS 90 (CODE NAME RD-2401)

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

    FDA 510(k)
    FDA Class 2 ·Immunology

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·January 17, 2020

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 3, 2014

    ARTICUL/EZE CER BALL 32+1

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code LZO·February 18, 2011

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016