BEUDAMED
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    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.

    FDA Enforcement
    Class II ·Terminated·Stryker Craniomaxillofacial Division·February 18, 2015

    MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code FTL·December 17, 2014

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Acumed LLC·March 22, 2017

    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    FDA Recall
    Terminated ·Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany·Product code FTM·December 29, 2021

    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument.

    FDA Recall
    Terminated ·Acumed LLC·Product code LXH·February 17, 2017

    MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032

    FDA Enforcement
    Class II ·Terminated·Stryker Leibinger GmbH & Co. KG·March 9, 2022

    LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IYN·September 2, 2004

    LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IYN·September 2, 2004

    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

    AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    AF w/AS 550x 0.5 7 ml/hr, 5ml 30 LO CPNB, Product code MVAX30XL CPNB, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.

    FDA Enforcement
    Class II ·Terminated·NxStage Medical, Inc.·August 22, 2018

    AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow AutoFuser Disposable Pain Control Pump

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·March 6, 2019

    Juxta-Lite compression wrap XLShort 28cm Length with Separate Small AFW Catalog 23126017

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Juxta-Lite compression wrap XL Long 33cm Length with Separate Medium AFW Catalog 23236017

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Juxta-Lite compression wrap XXL Short 28cm Length with Separate Medium AFW Catalog 23137017

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010

    Juxta-Lite compression wrap Medium Short 28cm Length with Separate Small AFW Catalog 23124017

    FDA Recall
    Terminated ·Circaid Medical Products Inc·Product code MDR·April 20, 2010