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

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    UNIKO PointCloud™ Knee Instruments

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482060858·Symmetry® Retractor, Spring, 1x1-Prong, Long

    ULTIMUM EV HEMOSTASIS INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    NAVIGATED CANNULATED 4.5MM TAP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·November 25, 2025

    SL 1 INTRODUCER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·March 10, 2011

    RESPONSE EP CATHETER UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRF·March 10, 2011

    TRANSSEPTAL NEEDLE, BRK SERIES

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·March 10, 2011

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC.·Product code MND·October 30, 2014

    ISOFLEX LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

    PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 18, 2013

    SINGLE USE GUIDEWIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code OCY·January 1, 2025

    BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement

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

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

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

    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, 80 MM, Silicone, Sterile, Item 433180.

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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025