BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ACRYLIC HERBST APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    OPTIFIX

    FDA UDI
    Davol Inc.·00801741074318·OptiFix Absorbable Fixation System, 39 cm lengt...

    JOBST forMen Casual

    FDA UDI
    BSN MEDICAL, INC.·00035664131265·FOR MEN CASUAL 20-30 MM HG KNEE HIGH CLOSED TOE...

    NEO / Kinetic Anterior Cervical Plate System

    FDA UDI
    Life Spine, Inc.·00190837036423·Variable Angle Drill Guide

    N LP(A) STANDARD SY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TROPHON CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 21, 2020

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 21, 2020

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 21, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 3, 2022

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·April 19, 2000

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 22, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 21, 2019

    PRESTO UP&UP BGMS

    FDA Adverse Event
    Injury ·AGAMATRIX, INC.·Product code NBW·May 4, 2015

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·May 9, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 22, 2014

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 20, 2011

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·February 4, 2015

    PARIETEX

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·May 7, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021