BEUDAMED
    15 results · 37ms · Sources: EU EUDAMED, US FDA

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    ENDOFLIP GASTRIC TUBE

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

    JOBST ActiveWear

    FDA UDI
    BSN MEDICAL, INC.·00035664006037·ACTIVE WEAR 30-40 MM HG LARGE FULL CALF COOL WH...

    Breast CT/MR Template

    FDA UDI
    Nucletron B.V.·08717213022270·Set of 5 template-pairs, 14 mm spacing,Double p...

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 31, 2014

    BD DIRECTIGEN EZ FLU A+B ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    SYSTEM 2000

    FDA Adverse Event
    Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code ILJ·April 11, 2013

    LIFECARE PCA 3 V5.06

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·September 16, 2014

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 1, 2011

    REDUCTION FORCEPS WITH POINTS RATCHET 174MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·August 2, 2021

    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021