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

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    Cove Putty, OsteoCove Putty

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD BBL™ Sensi-Disc™ Vancomycin 5 µg

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902310303·BD BBL™ Sensi-Disc™ Vancomycin 5 µg

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551081792·Nasal Cartilage Template, 1 mm

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102060·MEYERHOEFER CURETTE #3

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197122528·Capener Osteotome curved...

    RANGE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC EUROPE SARL·Product code MHY·October 30, 2008

    ICON 25 HCG (COMBO CASSETTE)

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·July 19, 2011

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 12, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 28, 2016

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 28, 2016

    SINGLE USE GUIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 6, 2025

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 4, 2024

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020