BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756192033·CRANIOTOMY PACK

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033338742·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115200·Needle, Bevel Stylet, Stainless Steel, Disposable

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033338759·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033338766·

    JDEVOLUTION PLUS

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 6, 2025

    WAKO AUTOKIT LP(A)/ RA,500/1000,

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING

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

    STERIL COV F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·March 19, 2013

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33%, CELLULOSE

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·February 25, 2011

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·March 10, 2008

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·October 3, 2023

    ACHIEVE MAPPING CATHETER - 20 MM

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DRF·October 3, 2023

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 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

    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