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    1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes

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

    ENDOBUTTON

    FDA UDI
    Smith & Nephew, Inc.·03596010497048·60 MM ENDOBUTTON CL BTB

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010611970·CEMENT MIXING SPATULA

    Dilator, Vascular, Memory 20cm 6.0mm alu-handle

    FDA UDI
    Geister Medizintechnik GmbH·04057034308561·Dilator, Vascular, Memory 20cm 6...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706374·Gillies (Converse) Skin Hook 7" (17.8cm), large...

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C31422100880·Titanium PLIF Spacer, 22 x 10 x 8mm, 8 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C30422100880·PEEK PLIF Spacer, 22 x 10 x 8mm, 8 deg

    REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEFENDO Y-OPSY IRRIGATOR

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

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 7, 2021

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2008

    ALIQUOT SYRINGE DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ORTHOVITA, INC.·Product code NDN·August 3, 2011

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 8, 2013

    INDIGO SYSTEM SEPARATOR 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

    GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·October 31, 2012

    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 19, 2014

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015