BEUDAMED
    25 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 ×

    ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673167·LEVAMED STABILI-TRI ANK SUP BLU L IV

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517576972·CoRoent Ant TLIF PEEK, 10x12x32mm 4°

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009687·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331166587·probe w/ eye, usa pattern, sterling silver, 5" ...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)

    MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK ACTIVE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    EKOSONIC KIT 106CM 12CM TZ

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·May 9, 2013

    SX OXYGENATOR W/HR X COATING

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·August 27, 2014

    COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GDW·May 19, 2011

    BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·February 21, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021