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

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    GlidePath 13F Long-Term Hemodialysis Catheter

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

    MONOPTY

    FDA UDI
    Bard Peripheral Vascular, Inc.·00801741084690·MONOPTY® Disposable Core Biopsy Instrument, 11m...

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551113416·HALO, 1203-5 VEST XX-LARGE, LAMBSWOOL LINER, 12...

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185619·AccuFit™ Molar Band UR7 - 41

    3D Printed Interbody Systems

    FDA UDI
    Seaspine Orthopedics Corporation·10889981303938·2-Hole No-Profile Interbody, 35mm x 27mm x 14mm...

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981309824·Trial Rasp, 35mm x 27mm x 14mm, 10 Deg

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981215385·No-Profile Interbody, 35mm x 27mm x 14mm, 10 Deg

    Liofilchem Mic Test Strip (MTS)

    FDA UDI
    LIOFILCHEM SRL·08055182873050·The MTS™ Tetracycline 0.016-256 μg/mL is a quan...

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821141000101·EXPERIENCE Mini ROTH 018/LR1&2-1T 2A

    NUVASIVE LONG LATERAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARA 5X

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLACKHAWK Cervical Spacer System

    FDA UDI
    Choice Spine, LP·00840996164467·BLACKHAWK,STERILE,LORDOTIC,14X12X10

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 3, 2021

    VERTVIEW CERVICAL PLATING SYSTEM

    FDA Adverse Event
    Injury ·ATLAS SPINE INC.·Product code KWQ·August 8, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    CURVE CUTTER STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 8, 2013

    Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·April 22, 2015

    Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code KNW·March 17, 2015

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025