BEUDAMED
    303 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 19, 2020

    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 19, 2020

    NDI P7 Position Sensor, Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 17, 2017

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

    FDA Enforcement
    Class II ·Terminated·Northern Digital Inc.·July 22, 2015

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

    FDA Enforcement
    Class II ·Terminated·Northern Digital Inc.·July 22, 2015

    ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology, Inc.·December 4, 2019

    bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·November 28, 2012

    bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·November 28, 2012

    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·November 28, 2012

    bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·November 28, 2012

    Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Ltd.·December 16, 2020

    Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·October 7, 2020

    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

    FDA Enforcement
    Class II ·Terminated·Epimed International, Inc.·March 24, 2021

    Rusch Greenlite Product Code: 004551002 GTIN: 14026704663115 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Rusch Greenlite Product Code: 004551004 GTIN: 24026704553796 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Rusch Greenlite Product Code: 004551035 GTIN:7290102156443 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Rusch Greenlite Product Code: 004550004 GTIN: 14026704663085 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Rusch Greenlite Product Code: 0004550003 GTIN: 14026704663078 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Rusch Greenlite Product Code: 004550002 GTIN: 14026704663061 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020

    Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    FDA Enforcement
    Class II ·Terminated·TELEFLEX MEDICAL INC·August 5, 2020