BEUDAMED
    18 results · 29ms · 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 ×

    LIGHTLAS 532 PHOTOCOAGULATOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890103720·Zirlux Titanium Abutment 4.5 mmH compatible wit...

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964150173·Endo Carry-on Procedure Kit Includes Intercept ...

    Vivid Elegance HTS Light FS

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724D0103720·50ml x 2

    Instrumed GmbH dba Avalign German Specialty Instruments

    FDA registration
    Instrumed GmbH dba Avalign German Specialty Instruments·97 products·🇩🇪 Germany

    POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    E-Z LINK CROSS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013

    VISX EXCIMER LASER

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013

    AXSYM DIGOXIN III

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007

    STENT CORONARY

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code MAF·March 19, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·March 8, 2011

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·December 14, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016