BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    NIAGARA SLIM-CATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890107780·Zirlux UCLA Plastic Abut N Eng

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450243312·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033237243·

    BD VACUTAINER® K2E (EDTA) 7.2MG PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 1, 2018

    POROCOAT PRODIGY HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 19, 2013

    LAMITRODE S-8 LEAD KIT, 90CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 2, 2011

    EPIC II PLUS DR

    FDA Adverse Event
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BLUNT TIP SCREW, 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 6, 2021

    BLUNT TIP SCREW, 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 7, 2021

    BLUNT TIP SCREW, 4X44MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·July 6, 2021

    M-VIZION FEMORAL REVISION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 20, 2024

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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