BEUDAMED
    16 results · 18ms · Sources: EU EUDAMED, US FDA

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    MARRIA-HPRL RIA KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Epimed International, Inc.

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788021397·Versa-Kath® 21g x 12" w/ RX Coudé 18g TW x 3.5"

    BoneCam

    FDA UDI
    MEDLINE INDUSTRIES, INC.·00818614021119·

    MSI

    FDA UDI
    Modern Surgical Instruments LLC·00810130203970·Stainless Steel Tray with Lid 405x255x50mm

    SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RANDOX DIGITOXIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CONNECTOR LUER LOCK C35

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 21, 2019

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·August 17, 2010

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·July 23, 2007

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia

    FDA Enforcement
    Class II ·Terminated·Epimed International, Inc.·July 31, 2019

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia

    FDA Enforcement
    Class II ·Terminated·Epimed International, Inc.·July 31, 2019

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 311291155 for epidural or caudal anesthesia

    FDA Recall
    Terminated ·Epimed International, Inc.·Product code BSO·June 18, 2019

    Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 units, Sterile ED, REF 181-2112, RX, (01) 108187880213945, LOT 31129344 for epidural or caudal anesthesia

    FDA Recall
    Terminated ·Epimed International, Inc.·Product code BSO·June 18, 2019

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024