BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    POLY INSERT 20 DEGREE

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 130

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 17, 2012

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471155978·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 230mm

    SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    Excelsior

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 19, 2016

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 1, 2016

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 17, 2013

    4 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 6, 2010

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 8, 2014

    Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912

    FDA Recall
    Terminated ·GF Health Products, Inc·Product code FNL·September 30, 2016

    Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026