BEUDAMED
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    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

    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

    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

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·September 6, 2017

    CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..

    FDA Enforcement
    Class II ·Terminated·Med Tec Inc·September 6, 2017

    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

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    FDA Recall
    Terminated ·Med Tec Inc·Product code KXH·August 10, 2017

    CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..

    FDA Recall
    Terminated ·Med Tec Inc·Product code KXH·August 10, 2017

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

    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code GDJ·June 29, 2018

    16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    FDA Recall
    Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018

    Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles

    FDA Recall
    Terminated ·COVIDIEN LLC·Product code HDA·March 13, 2019

    Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.

    FDA Recall
    Terminated ·Cooper Surgical, Inc.·Product code HDB·January 16, 2008

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code GDJ·July 2, 2013

    16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to facilitate its passage through the birth canal. The instruments are only used for female population. The product is non-powder, non-liquid, non-tablet, capsule or other.

    FDA Recall
    Terminated ·Fetzer Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen Germany·Product code HDA·December 28, 2018