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

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    Viz ICH

    FDA 510(k)
    FDA Class 2 ·Radiology

    TWINFIX / DURABRAID

    FDA UDI
    Smith & Nephew, Inc.·03596010001238·TWNFIX AB 6.5 STR ANCHR 2 DRBRD 38

    Pruitt Irrigation Occlusion Catheter

    FDA UDI
    Lemaitre Vascular, Inc.·00840663101542·Pruitt Irrigation Occlusion Catheter, 9F, eIFU

    Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

    FDA Recall
    Open, Classified ·LeMaitre Vascular, Inc.·Product code DQT·April 11, 2025

    Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023925·PADDLE SPREADER, 9MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102090·Shaver, Open 9mm

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721858·Cottle Osteotome 7" (17.5cm), 9mm wide, rounded...

    DeBakey Vessel Probe 19cm 8.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034048009·DeBakey Vessel Probe 19cm 8.0mm

    Pruitt Irrigation Occlusion Catheter

    FDA UDI
    Lemaitre Vascular, Inc.·00840663101535·Pruitt Irrigation Occlusion Catheter, 9F

    ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL

    FDA 510(k)
    FDA Class 2 ·Neurology

    PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Disc Prep

    FDA UDI
    Seaspine Orthopedics Corporation·10889981102111·7x9mm Tapered Spreader

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981027667·Pedicle Hook Large. The Coral Spinal System con...

    Stainless Steel

    FDA UDI
    Seaspine Orthopedics Corporation·10889981028336·Pedicle Hook Large. The Stainless Steel Spinal ...

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code FMF·October 22, 2008

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 27, 2013

    PREMIER ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 11, 2012

    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code QLT·November 8, 2021