BEUDAMED
    20 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    RADIOGRAPHIC INTENSIFYING SCREEN

    FDA 510(k)
    FDA Class 1 ·Radiology

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556601617·SOD OBTURATOR 7MM FOR 6901013

    Zavation

    FDA UDI
    Zavation LLC·00842166180789·Removal Drill

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746109157·DB BKT MINI MS UR CEN 018 T+17 A+4 R=0

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515226494·Buck Ear Curette, 1.0mm, sz 00, str, sharp

    SEALED CALL CORD, 8-PIN DIN, 1FT,JRW 790

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828157186·SEALED CALL CORD, 8-PIN DIN, 1FT,JRW 790

    TCP

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118127·

    ELECSYS ANTI-TPO CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    JOURNEY BCS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIACAM (510(K) K 901019)

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SYSTEMS·Product code KPS·March 13, 2001

    RCSP RETROGRADE CANNULA

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013

    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·February 14, 2018

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 30, 2014

    SPECTRUM

    FDA Adverse Event
    Malfunction ·SIGMA·Product code FRN·October 18, 2010

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2012

    ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9

    FDA Recall
    Terminated ·3M Company Health Care Business 3m Center·Product code NOC·November 1, 2017

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025

    OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·June 26, 2024

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024