BEUDAMED
    17 results · 22ms · 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 ×

    AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BONE GRAFT WASHER

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978958934·WASHER 9090117 TI BONE GRAFT 17MM

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027100·

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm

    NOOSA Anterior Lumbar Plate

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215019679·

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 2, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 2, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 2, 2023

    GUIDANT AXIUS CORONARY SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE

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

    AXXENT FLEXISHIELD MINI (K090417)

    FDA Adverse Event
    Injury ·XOFT, INC.·Product code IXI·January 7, 2011

    MEL80 EXCIMER LASER SYSTEM

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code LZS·June 29, 2017

    ELLIPSE DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

    OH PACK

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DWE·August 18, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10134 Sterrad 100NX Express Cycle Kit. 10135 Sterrad 100NX Express Cycle Upgrade Kit. 10137 Sterrad 100NX Duo Cycle Upgrade kit. 14325 Cyclesure Challenge Pack Kit. 20103 Sterrad 100NX Test Pack Kit. 20228 Sterrad 100NX Intl Validation Kit. 20229 Sterrad 100NX Validation Kit, USA. 20232 Sterrad 50/100S Validation Kit. 20236 Sterrad 50/100S Validation Kit. 20248 Sterrad 100NX Express Validation Kit. 20253 Sterrad NX Validation Kit. 20254 Sterrad NX Validation Kit Domestic, US. The Sterrad Cyclesure 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the Sterrad Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·December 19, 2012