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

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    TINA-QUANT APOLIPOPROTEIN B VER.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102060·Shaver, Open, 6mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023895·PADDLE SPREADER, 6MM

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033469163·

    ALLURA XPER FD

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code IZI·November 3, 2025

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112060·Tap, 6.50mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO

    Orbitum Staple System

    FDA UDI
    CPM Medical Consultants, LLC·B565FO20132060·2.0 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT

    DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005

    FDA 510(k)
    FDA Class 2 ·Radiology

    BA KIT,WE,P808,IG,6',BE,S37,INL,1'

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828139267·BA KIT,WE,P808,IG,6',BE,S37,INL,1'

    BA KIT,WE,P808,IG,6',BE,P37,INL,1'

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828120876·BA KIT,WE,P808,IG,6',BE,P37,INL,1'

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 23, 1998

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·March 15, 2013

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 10, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 12, 2008

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997

    HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134

    FDA Recall
    Terminated ·HemoSense Inc·Product code GJS·September 7, 2005

    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, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018