BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    ABBOTT ARCHITECT LH CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INTELLIO

    FDA UDI
    Midwest Products and Engineering, Inc.·00197644606863·Video Cart 120V

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180163294·WILLAUER SCISSORS, CURVED-BLUNT, 10" (25.4CM) O...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809265158752·

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015067·microSelectron Transfer Tube for Metal Needles ...

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390860819·

    TruFit™

    FDA UDI
    Ortho Organizers, Inc.·00190707191702·TruFit 2.0 018 ROTH UR6/7 NC SBT -10T 8Off DB S...

    D.SIGN 96

    FDA 510(k)
    FDA Class 2 ·Dental

    INFUSION ADAPTER C100

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    TRIDENT 0° X3 INSERT 36MM ID

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

    OPTICROSS?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code OBJ·September 23, 2014

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 12, 2008

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·April 28, 2023

    BD PYXIS¿ ANESTHESIA STATION ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·July 17, 2025

    MOZECTM NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·October 21, 2023

    Absorbable Collagen Sponge Provided As Intermediate to Another Company

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

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

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    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