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

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    Silk’n Toothwave

    FDA 510(k)
    FDA Class 2 ·Dental

    Oklahoma Gas & Electric - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588140780·Oklahoma Gas & Electric - 18 Metal

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114178·HALO, CTLSO VEST SMALL, LAMBSWOOL LINER, 1211-1...

    ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Stryker ProCinch Adjustable Loop Device

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERFORATOR DRIVER W/HUDSON END

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 30, 2014

    BIOLOX HIP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code LZO·July 19, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    VALIANT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 30, 2013

    TALENT TAA

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 30, 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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021