BEUDAMED
    20 results · 36ms · 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 ×

    SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741324350·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674132435060·

    AGXO

    FDA UDI
    Oticon A/S·05707131257574·H150, BTE 13 WL 85 STG AGXO

    Baby Gorilla/Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795145468·Ovr Dr Gd, Dbl End, 2.4/3.5mm, R3CON

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030872·AILERON Canted Static Posterior Fusion Plate, 1...

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030865·AILERON Canted Static Posterior Fusion Core, 15...

    BEYONDIMAGE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Baby Gorilla/Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795145475·Drl Gd Slv, 3.5mm, R3CON

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 29, 2013

    AFFINITY 4

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·August 22, 2008

    ENTERPRISE ACCESS

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DQK·June 13, 2011

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HRS·November 6, 2017

    THERMAGE CPT SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020

    THERMAGE CPT SYSTEM TIP

    FDA Adverse Event
    Injury ·SOLTA MEDICAL INC·Product code GEI·November 30, 2022

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023