BEUDAMED
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    ADT NERVE BLOCK TRAY(DISP.)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MGB Alert® CMV 3.0 Probe Mix ASR - 48 Reaction

    FDA UDI
    Elitechgroup Mdx LLC·03661540951541·"MGB Alert® CMV 3.0 Probe Mix is an analyte spe...

    Comforsil

    FDA UDI
    PRIM S.A.·08431082070902·Nocturnal "Hallux Valgus" bunion corrector, pair

    ACUMED

    FDA UDI
    Acumed LLC·10806378042072·Ulnar Shortening Reduction Clamp

    S52D DIGITAL VIDEO LAPAROSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INTEGRE, MODEL LP581

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIODESIGN 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTM·April 3, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

    Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837

    FDA Recall
    Open, Classified ·3M Company Health Care Business 3m Center·Product code NXC·November 22, 2024

    Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.

    FDA Recall
    Terminated ·Product code NBE·July 28, 2011

    Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·August 4, 2008

    Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood glucose targets.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·August 4, 2008

    Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood glucose targets.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·August 4, 2008

    Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood glucose targets.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·August 4, 2008

    Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets.

    FDA Recall
    Terminated ·Animas Corporation·Product code LZG·August 4, 2008

    Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN

    FDA Recall
    Terminated ·Synovis Surgical Innovations, Inc.·Product code GXQ·October 28, 2013

    Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N

    FDA Recall
    Terminated ·Synovis Surgical Innovations, Inc.·Product code DXZ·October 28, 2013

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021