BEUDAMED
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    GENESIS OTC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code MDB·August 3, 2023

    PTA BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·April 16, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER INC.·Product code MMI·April 18, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 13, 2008

    EASYLINK

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JQP·November 25, 2014

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

    EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·July 23, 2010

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018