BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    DIMENSION PENTA H, DIMENSION PENTA H QUICK

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062371·Endoflex Hedstrom Files 21 mm

    Nobel

    FDA UDI
    Preat Corporation·00842092101100·NobelBiocare™ Tri-Lobe-compatible RP Snappy Abu...

    Sledgehammer

    FDA UDI
    Keystone Industries·H66810005911·20 Min Qt Liquid

    Non-Telescopic PenEvac

    FDA UDI
    I.C. MEDICAL, INC.·00817688022800·Non-Telescopic PenEvac®, Stainless Steel Blade,...

    MFCD 118

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOLOX DELTA CER HEAD 28 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·January 21, 2016

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 6, 2012

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·March 12, 2013

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·February 2, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC·Product code JAA·February 21, 2008

    FISCHER CONE BIOP EX M/EX

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·February 28, 2020

    REFORM PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·PRECISION SPINE, INC.·Product code HXX·November 11, 2021

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·May 16, 2025

    IBP ULNA RIGHT SM INTLK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWI·January 31, 2020

    BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013

    BrightView, Gamma Camera System, Product Code 882480.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016