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    BAYER RAPIDPOINT 405 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040162207·Channels Flex Gutta Percha Points 30.04

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·00843717108467·College Pliers 6", Serrated Tips

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113393·PS Insert, Size 6 x 16mm

    Merit Medical Singapore Pte. Ltd.

    FDA registration
    Merit Medical Singapore Pte. Ltd.·13 products·🇸🇬 Singapore

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106160·Trial, 26 x 16mm, 8 Degree, Tapered, Straight

    SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SAFEDRAW BLOOD SUPPLY SYSTEM

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SINGAPORE PTE LTD.·Product code DSK·December 17, 2018

    Mayo-Hegar Needle Holder

    FDA UDI
    ELMED INSTRUMENTS(PVT)LTD.·G165SU130206160·Intended Use: Mayo Hegar Needle Holder is commo...

    INFINITY DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO., INC.·Product code DZE·March 21, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 16, 2011

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·March 28, 2008

    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

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017