BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694020435·FPS 3.5mm x 45mm Standard Screw

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103797·Modular 3 SA Wave Retention Grasper,Insert only...

    Mediflex Modular III Basic Laparoscopic Instruments

    FDA UDI
    FLEXBAR MACHINE CORPORATION·00842102103780·Modular 3 Wave Retention Grasper, Single-Action...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694074582·FPS 3.5 x 45mm Screw Sterile Qty 2

    SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221

    FDA 510(k)
    FDA Class 2 ·Hematology

    VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2024

    ETHICON

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY·Product code LFL·October 27, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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