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    JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    ASAHI PROWATER

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 9, 2019

    ACTIVELIFE

    FDA UDI
    CONVATEC, PURCHASING DEPARTMENT·00768455101528·Activelife® One-Piece Pre-Cut Drainable Pouch W...

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003689·KoKo Pulmonary Function Filter Kit, White with ...

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746156090·LIGATURE 20 STICK ROSE 50/BAG

    Ligatures

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746077289·LIGATURE 20 STICK ROSE 50/BAG

    MJS POSTERIOR STABILIZED KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GATIFLOXIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTP·March 22, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 17, 2011

    INDURA

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·March 28, 2008

    COLUMBUS UCR TIBIAL PLATEAU CEMENTED T2+

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code JHW·July 24, 2015

    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