BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    ZIESS ENDOPROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2

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

    MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014

    TOTAL CARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 28, 2012

    PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025

    GENESIS UNI KNEE FEMORAL COMPONENT COCR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025

    Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63CCC34, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (5) Presource Robotic Module Pack, Cat. SBAOCRBENF, Englewood Hospital and Medical, Sterile; (6) Presource Robotic Module Pack, Cat. SBAOCRBEN8, Englewood Hospital and Medical, Sterile; (7) Presource FMC Liver Resection Pack, Cat. SBA30MJCHH, AHS Calgary Zone, Sterile; (8) Presource ALIF Pack, Cat. SBA41ALFME, USPI Baylor Med Ctr at Fri, Sterile; (9) Presource ACDF Pack, Cat. SBA44ACWBF, Webster Surgical Specialty Hos, Sterile; (10) Presource Lap Chole Pack, Cat. SBA54LADNA, USPI Paso Del Norte Srgry Ctr, Sterile; (11) Presource Lap Chole Pack, Cat. SBA54LADN3, USPI Paso Del Nrte Srgry Ctr, Sterile; (12) Presource Salle Hybride Ensemble, Cat. SCV30THLHA, Inst Univ Cardio ET Pneumo, Sterile; (13) Presource AMB Perc Pack, Cat. SMA57PR00B, Oregon Health Science Universi, Sterile; (14) Presource KP Vacaville Lami Pack, Cat. SNE69LPKVB, KP Vacaville, Sterile; (15) Presource Kyphoplasty Pack, Cat. SOP26KPMHB, Moffitt Cancer Center, Sterile; (16) Presource Percutaneous Nephro Pack, Cat. SOT30PELCA, Lakeridge Health Corporation, Sterile; and (17) Presource PBDS Infection Control Turnover Kit, Cat. ORC511687B, Sequoia Surgery Center LLC, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Cardinal Health 200, LLC·October 18, 2023