BEUDAMED
    20 results · 21ms · 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 ×

    Monoject Enteral Feeding Syringe with ENFit Connector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024268·B-P MODULAR EXTENSION W/ULTRACOAT - 19 MM X 100 MM

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH INC.·Product code MZF·June 4, 2018

    CONCERTO BIPOLAR NEEDLE ELECTRODE

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

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PENUMBRA MAX PUMP - INDIGO SYSTEM

    FDA Adverse Event
    Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Injury ·ORGENICS LTD·Product code MZF·July 14, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014

    CAPSURE SENSE

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 10, 2013

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·June 20, 2011

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 12, 2016

    GALAXY G3 XSFT HEL 2MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·February 16, 2021

    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·December 25, 2019

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015