BEUDAMED
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    TISSUE SITE MARKING SYSTEM

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

    Able Medical Devices

    FDA UDI
    J.M. Longyear Manufacturing, LLC·00810071391453·Ball End Temporary Fixation Pin

    ICE

    FDA 510(k)
    FDA Class 2 ·Dental

    SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA·Product code MNI·April 17, 2013

    VISISTAT 35W

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·March 21, 2011

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·June 20, 2008

    BASE SYS BI70002000 O-ARM SYS O2

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·March 17, 2020

    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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015