BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000987·1.6mm x 8mm Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694018784·1.6mm x 8mm Lag Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694029360·1.6mm x 8mm Screw, Sterile

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694067201·HPS 1.6 x 8mm Lag Screw Sterile Qty 5

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694054454·1.6mm x 8mm Screw Sterile Qty 10

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 8, 2025

    MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BLAINE SCARCARE PATCH

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 29, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 13, 2011

    ONE TOUCH ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·July 25, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024