BEUDAMED
    13 results · 28ms · 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 ×

    GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033867·Baltic Denture System B Load BDLoad ↓ Sm6 PLSEu...

    XIVE DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NO CODE AVAILABLE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code GXN·March 8, 2016

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code FPB·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 17, 2011

    PUMP MMT-712LNAL PRDGM INS CL EN US LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·April 24, 2008

    PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code GWO·June 21, 2016

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013