BEUDAMED
    14 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 ×

    CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C

    FDA 510(k)
    FDA Class 2 ·Neurology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099570·MAX 1ST MOLAR LEFT 92 BANDS

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange

    Single Use Surgical Optical Fiber

    FDA UDI
    QUANTA SYSTEM SPA·08033945937270·Single Use Surgical Optical Fiber ø 800 µm Dist...

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code BTR·February 26, 2014

    X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

    FDA 510(k)
    FDA Class 1 ·Radiology

    RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LANX SPINOUS PROCESS FUSION PLATE

    FDA Adverse Event
    Injury ·LANX, INC.·Product code KWP·March 17, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 19, 2013

    A5 ANESTHESIA DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code BSZ·August 18, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 4, 2011

    BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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