BEUDAMED
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    LIQUICHEK URINE CHEMISTRY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743717·ACHIMED ACHILLES SUPP SAND II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743700·ACHIMED ACHILLES SUPP SAND I

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743724·ACHIMED ACHILLES SUPP SAND III

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120208171·Carbide - Excavating and fissure burs

    SYNETEC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMEGA II MODULAR TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EECP THERAPY SYSTEM, MODEL TS3

    FDA Adverse Event
    Injury ·VASOMEDICAL, INC.·Product code DRN·December 30, 2002

    11.0MM TI HELICAL BLADE 115MM

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code HSB·March 26, 2013

    INFUSOR TWO DAY 2ML/HR 12 PK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 16, 2011

    MORPHEUS CT PICC

    FDA Adverse Event
    Malfunction ·Product code LJS·December 21, 2007

    SMART MONITOR 2

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS, INC.·Product code FLS·May 26, 2011

    SMART MONITOR 2

    FDA Adverse Event
    Death ·PHILIPS RESPIRONICS, INC.·Product code FLS·February 3, 2012

    SMART MONITOR 2

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code NPF·October 1, 2010

    SMART MONITOR 2

    FDA Adverse Event
    Other ·PHILIPS RESPIRONICS, INC.·Product code FLS·December 3, 2010

    SMARTMONITOR 2

    FDA Adverse Event
    Death ·PHILIPS RESPIRONICS, INC.·Product code FLS·March 31, 2011

    Vertical Brake Hubs component of the Philips MX8000 Series Dual v. Exp. Computed Tomography System, Serial Numbers: 8008-8413, 80001-800022, Model #728130, 510 (k) #K010817. Product Usag: The MX 8000 series Dual v. Exp are Computed Tomography X-Ray system units intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 3, 2011

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    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