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

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    Glidewell Appliance Resin, Hard/Soft

    FDA 510(k)
    FDA Unclassified ·Unknown

    NA

    FDA UDI
    Richard Wolf GmbH·04055207014431·BRONCHOSCOPE-TUBE ID 10.5MM model Wolf, OD 11....

    ESR-Chex

    FDA UDI
    STRECK, INC.·00844509001621·A two-level hematology control used to monitor ...

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114383·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 L...

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857522268·Trial Size 13x16x9 mm, 12°

    PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Topwide Surgical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·October 25, 2013

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 10, 2013

    TISSUE RETRIEVAL BAG

    FDA Adverse Event
    Other ·ANCHOR PRODUCTS CO.·Product code GCJ·July 18, 2011

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·August 14, 2014

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 9, 2013

    Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

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

    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

    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012