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

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    HEMOSIL ANTITHROMBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    Vial Adaptor

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240160·Vial Connector 13mm FLL Orange- VF

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694109·Pilot Guided Drill Spade

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699203·Titanium Base Abutment Round Anterior, Int. Hex...

    CollaFlex

    FDA UDI
    UNICARE BIOMEDICAL INC.·D767C0703010·Resorbable COLLAFLEX® membranes are derived fro...

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 19, 2020

    MODIFICATION TO VISTA STEREOSCOPE SYSTEM

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

    IMMUNOWELL EA (D) IGG TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·January 20, 2010

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 4, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 27, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 9, 2008

    AFP ¿1-FETOPROTEIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LOJ·July 22, 2016

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024