BEUDAMED
    15 results · 35ms · 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.

    HELENA ULTRA SENSITIVE CPK REAGENT/DILUE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517353306·PRECEPT Base, Open Instrument

    NUPRO® Prophylaxis Paste with Fluoride

    FDA UDI
    DENTSPLY INTERNATIONAL INC.·D0038013181·NUPRO® Prophy Paste, Orange Vanilla Swirl, Medi...

    Symmetry Potts-Smith

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482126882·Symmetry® Scissors, Potts-Smith Razor Dissecting

    CPAP SYSTEM, MODEL 102001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KONG-C VBR M, Body, 18 mm

    FDA UDI
    icotec AG·07640164849690·KONG-C VBR M, Body, 18 mm

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 8, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

    FEM. MODULAR HEAD - L Ø36MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code LPH·October 25, 2018

    LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology

    FDA Recall
    Terminated ·Laser Peripherals LLC·Product code GEX·June 20, 2014

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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