BEUDAMED
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    LA-SPORO ANTIBODY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092179826·Sphero Block Abutment Straumann BLT 2.9 x 2mm (...

    SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SYNGO MR B17

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINEAGE(R) PC HA QUAD HEMI FLARE STANDARD SHELL

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·May 9, 2014

    CONTINUOUS WAVE III ARTHROSCOPY PUMP

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRX·October 24, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 28, 2015

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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