BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    PRIMA Humeral System and SMR Glenosphere Ø42

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049958002618·Medilas H30 Solvo Holmium Laser with wired foot...

    BAK®

    FDA UDI
    BIOMET SPINE LLC·00887868259999·

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127022418·Femoral Head, 28mm, -3.5mm, Biolox

    BP® Lordotic

    FDA UDI
    ZIMMER SPINE, INC.·00889024338616·

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04582667991687·

    SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUNTOUCH TOPICAL HEMOSTATIC DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ARTERIAL CATH SET: 20 GA X 3-1/16"

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQX·August 4, 2014

    ROTANTA

    FDA Adverse Event
    Malfunction ·HETTICH·Product code JQC·August 15, 2011

    UNK

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 9, 2013

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023