BEUDAMED
    24 results · 22ms · Sources: EU EUDAMED, US FDA

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    SeaSpine WaveForm™ A Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010508362·SWITCHING STICK, CANNULATED

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108271·5 MM DIA., 45 CM, INSULATED SPATULA ELECTRODE,...

    BD PRECISIONGLIDE NEEDLE 16G X 1

    FDA Adverse Event
    Malfunction ·BD·Product code FMI·February 9, 2022

    AMBU GEL, HYDROGEL BURN DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SENSITITRE OPTIREAD

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

    BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 16 G

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 24, 2022

    PINN MAR +4 NEUT 32IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 22, 2008

    THERMAGE

    FDA Adverse Event
    Injury ·SOLTA MED·Product code GEI·August 10, 2011

    ATLAS PLUS VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    INDIGO SYSTEM SEPARATOR 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

    BD¿ NEEDLE 1 IN. SINGLE USE, STERILE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 17, 2022

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026