BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776180157·HUDSON EWALD FORCEPS TEETH

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169604766·SPACER 2130255 OLIF25 27MM 0 DEG 10X55

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378365·Integra® Jarit® Ewald (Hudson) Forceps, 4-7/8",...

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925012059·GUILFORD CHISEL 25 DEGREE BLADE ANGLE 1.14 MM B...

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584979·Apex Tibial Nail Ø 13 x 255mm

    SILICONE DUAL LUMEN RADPICC CATHETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    STOPCOCK MANIFOLD GANGS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 24, 2013

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 30, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 13, 2011

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015