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

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    Rapid LVO

    FDA 510(k)
    FDA Class 2 ·Radiology

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216027924·ANATOMIC PEEK w/ Nano 14 x 11 x 9 x 10°

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777587·LUMBAMED BASIC DORSAL STAY WM SILVER I

    10PW - Oregon Body Fluid

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588009414·10PW - Oregon Body Fluid

    PALOMAR LUXG HANDPIECE

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

    STERLTECH WATER PURIFIER

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·March 1, 2016

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 25, 2025

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·July 1, 2011

    SINGLE USE 3-LUMEN SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code KNS·September 16, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO JUNCOS·Product code LGW·July 2, 2013

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code MNI·October 21, 2021

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 21, 2013

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2019

    AZURION

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 12, 2026

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018