BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    CHASE CARDIOVASCULAR PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104071·3i Certain 3.4mm x 6mm Titanium Base

    Preat

    FDA UDI
    Preat Corporation·00842092169810·Biomet 3i Certain®-compatible 3.4mm X 6.0mm Eng...

    GOLDFINGER DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RANDOX FERRITIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 7, 2014

    0001222315-2025-001662

    FDA Adverse Event
    Injury ·STRAUMANN MANUFACTURING, INC.·Product code DZE·June 18, 2025

    MOTIFMESH SOFT TISSUE PATCH (OMYRA MESH)

    FDA Adverse Event
    Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·October 25, 2013

    OMNIPOD 5 POD

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·March 27, 2025

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 13, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·February 18, 2011

    MICROMAX SYSTEM CUTTERS

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT·Product code ERL·February 14, 2008

    OMNIPOD 5 PODS

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·August 14, 2025

    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

    FDA Recall
    Open, Classified ·Product code QFG·March 12, 2026

    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

    FDA Enforcement
    Class I ·Ongoing·Insulet Corporation·April 22, 2026

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·July 19, 2021

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·July 19, 2021

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·July 19, 2021

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016