BEUDAMED
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    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

    FDA Enforcement
    Class II ·Terminated·Sentec AG·August 22, 2012

    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

    FDA Enforcement
    Class II ·Terminated·Nanosphere, Inc.·October 1, 2014

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019

    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·October 12, 2016

    GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures. The Cathiab Frontiers solutions are indicated for use in conjunction with single plane and biplane GE angiographic X-ray systems and imaging / data medical devices used in interventional and surgical cathlab environments and cleared for commercial distribution. The Cathiab Frontiers solutions are integrated GE angiographic X-ray and imaging / data medical devices that simplify the end-to-end clinical workflow in the cathlab by implementing: 1) Communication protocols for exchanging and automatically synchronizing patient, exam, system, and image information between the angiographic X-ray systems and the imaging / data medical devices. 2) Communication protocols for the control of imaging / data medical device functions from the angiographic X-ray systems user interface. 3) Interfaces for displaying the imaging / data medical device output on the monitor display solutions of the GE angiographic X-ray systems.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 5, 2014

    CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·August 12, 2020

    Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with needle.

    FDA Enforcement
    Class II ·Terminated·KooJoo Trading Company·July 24, 2013

    Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

    FDA Enforcement
    Class II ·Terminated·Won Industry Co.·December 13, 2017

    Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

    FDA Enforcement
    Class II ·Terminated·CORENTEC CO., LTD·March 22, 2017

    Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.

    FDA Enforcement
    Class II ·Terminated·Won Industry Co.·December 13, 2017

    Miriam Capsule Endoscope System. Model MR1100 Product Usage: MiroCam Capsule Endoscope System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults.

    FDA Enforcement
    Class II ·Terminated·IntroMedic Co., Ltd.·May 9, 2018

    Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)

    FDA Enforcement
    Class II ·Terminated·ShinChang Medical Co., Ltd.·September 26, 2018

    Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.

    FDA Enforcement
    Class II ·Terminated·U&I CORP.·May 6, 2020

    DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    FDA Enforcement
    Class II ·Terminated·Mediana Co., Ltd.·July 8, 2020

    Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F

    FDA Enforcement
    Class II ·Terminated·Taewoong Medical Co., Ltd.·February 19, 2020

    ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

    FDA Enforcement
    Class II ·Terminated·U&I CORP.·July 29, 2020

    AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

    FDA Enforcement
    Class II ·Terminated·Mediana Co., Ltd.·July 28, 2021