BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    SAFEPORT MANIFOLD (TM) (OR STOPCOCK)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756611695·Shoulder Immobilizer

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193109107·HA PEEK EVOS Straight, ,16mmx11mmx 30mm , FLAT ...

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158218246·DIRECTOR GROOVED 6.25"

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321110160·

    ANS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·May 14, 2013

    ENTERPRISE 8000

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH·Product code FNL·April 21, 2011

    IMPELLA RECOVER LP 2.5 PECUTANEOUS CARDIAC S

    FDA Adverse Event
    Injury ·ABIOMED·Product code KFM·August 12, 2008

    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

    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