BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780736·LEVAMED ACTIVE ANKLE SUP SLVR L I

    PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CoverLoc™ Volar Plate

    FDA UDI
    TORNIER, INC.·00846832001231·VOLAR PLATE

    ROLLO 112x30x16I/QT-HS/RED GRID

    FDA UDI
    AB MEDICA GROUP, S.A.·08428763059561·

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014950·Zirlux 16+ A1 65x25x22

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112220·Tap, 4.75mm Cortical, SNI1

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0112220·Tap, 4.75mm Cannulated, Fixed Sleeve

    LASER 20

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MALE LATEX COMDOM WITH DOTTED SURFACE

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

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 30, 2025

    XPS® BUR GUARD - VISAO®

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ERL·April 22, 2016

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    XPS® BUR

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code EQJ·March 13, 2017

    INTROCAN SAFETY

    FDA Adverse Event
    Other ·B. BRAUN MELSUNGEN AG·Product code FOZ·March 15, 2013

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·March 8, 2011

    DISPOSABLE PENCIL

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code GEI·January 31, 2008

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    FDA Enforcement
    Class II ·Ongoing·Lacrimedics Inc·March 9, 2022

    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

    FDA Enforcement
    Class II ·Ongoing·Lacrimedics Inc·March 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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019