BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    FDA UDI
    Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm

    MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743564·LEVAMED ANKLE SUPPORT SILVER V

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102150·Shaver, Open 15mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023987·PADDLE SPREADER, 15MM

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm

    QUIK-CHECK HOME PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HUB CAP® WRIST FUSION PLATE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·April 30, 2019

    HUB CAP® WRIST FUSION PLATE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·April 30, 2019

    HUB CAP® WRIST FUSION PLATE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·April 30, 2019

    HUB CAP® WRIST FUSION PLATE

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·April 30, 2019

    DIDECO LILIPUT ECMO M PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 20, 2012

    ON-Q PUMP 270ML, 5ML/HR

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·April 20, 2015

    BECKMAN COULTER AU680 CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·March 20, 2013

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·March 8, 2011

    KENTROX SL-S 65/16

    FDA Adverse Event
    Malfunction ·BIOTRONIK, GMBH AND CO.·Product code LWS·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

    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