6 results
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28ms
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Sources: EU EUDAMED, US FDA
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Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.
FDA Enforcement
Class II
·Terminated·Medtronic Vascular, Inc.·November 13, 2013
The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).
FDA Enforcement
Class II
·Terminated·ZYTO Technologies, Inc.·July 13, 2016
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.
FDA Enforcement
Class II
·Terminated·Assuramed·September 25, 2013
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.
FDA Enforcement
Class II
·Ongoing·Elucent Medical Inc·January 15, 2025
The ZYTO Tower is the input device to program the software with various virtual items.
FDA Enforcement
Class II
·Terminated·ZYTO Technologies, Inc.·July 13, 2016
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray
FDA Enforcement
Class II
·Terminated·Custom Assemblies Inc·August 30, 2017