BEUDAMED
    19 results · 28ms · 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.
    Filters Regulation: Us FDA ×

    Gynatrof

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Capo Natural A 1, 4 g

    FDA UDI
    Schütz Dental GmbH·ESDG2320401·Capo Natural is a light-curing composite contai...

    MEGA PLUS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665580559·Rod(CoCr), Ø5.5 x 400mm

    ihcDirect® SOX10 Ab, 15mL

    FDA UDI
    NOVODIAX, INC.·00850000596504·Clone R1008

    ihcDirect® SOX10 Ab, 5mL

    FDA UDI
    NOVODIAX, INC.·00850000596498·Clone R1008

    ihcDirect® SOX10 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934130·Clone R1008

    ihcDirect® SOX10 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934147·Clone R1008

    TSI Stem Broach

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040482·

    VIAL CONNECTOR 13MM CLOSED COLLAR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·September 1, 2011

    PROXIMATE ILS CIRCULAR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 6, 2014

    12/14 ARTICUL 40MM M SPEC+8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 17, 2013

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 16, 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 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

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

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