BEUDAMED
    17 results · 33ms · Sources: EU EUDAMED, US FDA

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    EASYRA CREATININE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011123586000·Super hard metal burs, with cross toothing cut,...

    DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

    FDA 510(k)
    FDA Class 2 ·Radiology

    IOS FASTSCAN SPRAY

    FDA 510(k)
    FDA Class 2 ·Dental

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 31, 2022

    TRIATHLON P/A CR BEADED #5L

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MBH·January 29, 2024

    PARADIGM INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code LZG·June 13, 2016

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·May 17, 2013

    GEM PREMIER 4000

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code CIG·June 10, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

    TRIATHION

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    TRIATHION COMPONENT

    FDA Adverse Event
    Injury ·HOWMEDICA OSTEONICS CORP.·Product code JWH·December 14, 2023

    Inserter for Titanium Elastic Nails (TEN), orthopedic device

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 21, 2015

    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 18, 2015

    Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical Europe Ltd·April 18, 2018

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012