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

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    MPO Hip Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Medos International Sàrl·10886705003273·DOVETAIL DRILL GUIDE Durable drill guide device

    DIGITAL ELECTROCARDIOGRAPHS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV

    FDA 510(k)
    FDA Class 2 ·Dental

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 18, 2023

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 18, 2023

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 30, 2023

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT IRELAND·Product code CBK·October 22, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 17, 2011

    ALIGN S URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 3, 2013

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·April 10, 2024

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024

    LIFE SCOPE G9

    FDA Adverse Event
    Malfunction ·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023

    ALINITY CI-SERIES SYSTEM CONTROL MODULE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·June 26, 2024

    ARCHITECT B12 REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CDD·November 4, 2024

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019