BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Single Use Guide Sheath Kit-401, K-402

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bernafon

    FDA UDI
    Bernafon AG·05711584114339·AN3, BTE SP 2.4G NFM SABE ALTENA 3 GPL

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704514490·

    REPROCESSED ARTHROSCOPIC SHAPERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Personal Lubricant Jelly

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEFINIUM 8000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·October 3, 2011

    DEFINIUM 8000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·August 3, 2012

    DEFINIUM 8000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code KPR·September 18, 2012

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·August 10, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·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

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    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