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

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    ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HI-TORQUE CONNECT

    FDA UDI
    ABBOTT VASCULAR INC.·08717648175053·Hi-Torque Connect 250T Guide Wire .018" 300 cm

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·00304040132975·Zirlux TR B3 98x14mm

    n/a

    FDA UDI
    Ortho Development Corporation·00822409072675·Blunt Tip Broach Size 9.5

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450448069·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033445884·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033423684·

    CBS STRAW

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DJ ORTHOPEDICS INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·March 15, 2019

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular, Inc.·January 1, 2014

    BARD PARKER

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·February 21, 2013

    UNKNOWN DEPUY GLOBAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSD·February 24, 2011

    LINOX SD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK, GMBH AND CO.,·Product code LWS·March 12, 2008

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·February 4, 2019

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2018

    SYRINGE 10ML LL W/NDL 21X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 2, 2020

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code KNS·August 8, 2019

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    FDA Recall
    Terminated ·Abbott Vascular, Inc.·Product code DQX·November 25, 2013

    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