BEUDAMED
    16 results · 25ms · Sources: EU EUDAMED, US FDA

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    PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT)

    FDA 510(k)
    FDA Class 2 ·Dental

    GRADIA®

    FDA UDI
    Gc America Inc.·D0479010771·GRADIA PLUS Paste HB-EL, 3.3ml, 1pc

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094251562·TAA REMOTE MONITORING SCALE

    Symmetry Allis

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482129227·Tissue Forceps 10 mm

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024201927·

    LUBRIGEL PERSONAL LUBRICANT

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

    OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RCSP RETROGRADE CANNULA

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    ENDO STITCH 10 MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code KOG·November 10, 2010

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·June 30, 2014

    2122870-2016-00090

    FDA Adverse Event
    Malfunction ·February 19, 2016

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019