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

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    CUR Model 1

    FDA 510(k)
    FDA Class 2 ·Neurology

    VIVID POST TRANSLUCENT

    FDA UDI
    BIOLOREN SRL·08056099233241·Cylindrical fiberglass light transmitting posts...

    Optiview

    FDA UDI
    ORMCO CORPORATION·00889989059991·OPTIVIEW REFILL CUSHION 10PK

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705322·DeBakey Crile-Wood Needle Holder 8" (20cm), ser...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100520·Caddie, 6.5mm Screws

    Placental Alpha Microglobulin-1 Immunoassay

    FDA Pre-Market Approval
    FDA Class 3 ·PartoSure test

    GE LIGHTSPEED XTRA CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CVINSIGHT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Placental Alpha Microglobulin-1 Immunoassay

    FDA Pre-Market Approval
    FDA Class 3 ·PartoSure Test

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

    25 GA POSTERIOR WIDE-FIELD ELITE PACK

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

    POLYFLUX 170H

    FDA Adverse Event
    Injury ·GAMBRO DIALYSATOREN GMBH·Product code KDI·October 10, 2014

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·July 13, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013

    STELLARIS POWER SUPPLY II

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

    BAROUK SCREW - 3 0MM X 32MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·April 7, 2020

    The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.

    FDA Recall
    Terminated ·USA Instruments Incorporated·Product code LNH·January 31, 2007

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024