BEUDAMED
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    bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical 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, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical 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, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical 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, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical 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 Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical 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 Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical 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 Recall
    Terminated ·Biomerieux Inc·Product code MDB·October 16, 2012

    MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HDW·May 20, 2015

    Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code HDW·February 26, 2013

    Milex Arcing Diaphragm Size 95; Model Number: MXWS95

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HDW·February 16, 2016

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·January 18, 2017

    Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Systems used for diagnostic ultrasound imaging or fluid analysis of human body.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IYN·August 12, 2008

    1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GCJ·March 5, 2013

    1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GCJ·March 5, 2013

    1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 17, 2014

    1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 17, 2014

    Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IYN·May 29, 2008

    Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IYN·May 29, 2008

    Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IYN·May 29, 2008

    Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·December 21, 2016

    1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code GCJ·March 5, 2013