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

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    ArthrexVIP Web Portal

    FDA 510(k)
    FDA Class 2 ·Radiology

    Young

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302731536125·Young DPA Contra, Latex Free, Turbo Plus, Soft,...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507844·Gutta Percha Points is used to root canal filin...

    Sklar

    FDA UDI
    SKLAR CORPORATION·30649111187968·TUMBLER 7OZ 2 7/8 X 3 1/8 PK12

    DRI-STAT ACID PHOSPHATASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISA ENZ 2 CAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·August 23, 2018

    ASSY PAT CIRC PEEPLESS ADULT SPU

    FDA Adverse Event
    Injury ·CAREFUSION·Product code CAI·December 30, 2015

    AGC D/A TIB BRNG 71X12

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 18, 2018

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 7, 2011

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    FORTIFY VR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·October 8, 2014

    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·November 4, 2020

    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·November 4, 2020

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-23, c) 44, 47, 50, 53 head, Large, Item Number 314-04-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-04-25; Shoulder Arthroplasty

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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