BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

    FDA Enforcement
    Class II ·Terminated·Stryker Corporation·March 14, 2018

    GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 31, 2018

    NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3. 3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4. The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner

    FDA Enforcement
    Class II ·Terminated·NeoCoil, LLC·March 9, 2016

    Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm

    FDA Enforcement
    Class II ·Terminated·SA3, LLC·April 13, 2022

    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T MR750W GEM ENAB (5911000-3); E. 3.0T MR750W GEM ENABLED (5352293, 5481490-2, 5481490-2, 5396469-3, 2394952-100, 5911000-3, 5373011-3); F. 3.0T MR750W GEM ENABLED PLU (5352293); G. 3.0T MR750W GEM ENABLED PLUS (5352293, 5499460-10); H. 3.0T MR750W W GEM (5352293, 5911000-3); I. 3.0T MR750W WITH GEM (5481490-2, 5911000-3); J. 3-0T MR750 32 CHANNEL (5352293); K. 3-0T MR750W FUTURE GEM CAPABLE (5352293, 5911000-3, 5499460-7); L. 3-0T MR750W GEM (5495558, 5352293); M. 3-0T MR750W GEM ENABLED (5911000-3, 5352293, 2394952-100, 5481490-2, 5499460-7, 5373011-3, 5495558, 5481490, 5396469-3, 5481490-3); N. 3-0T MR750W GEM ENABLED PLUS (5911000-3, 5352293, 5499460-10, 5481490-2); O. 3-0T MR750W NON GEM (5911000-3); P. 3T 750W (5921000-2, 5911000-3, 5396469-3, 5352293, 5481490-2, 5481490-3); Q. DISCOVERY MR 750W 3.0T (5481490-2, 5911000-3, 5499460-10); R. DISCOVERY MR750W (5911000-3); S. DISCOVERY MR750W 3 (5481490-2, 5911000-3); T. DISCOVERY MR750W 3T (5911000-3, 5396469-3, 5373011-3, 5481490-2); U. DISCOVERY MR750W GEM (5396469-3, 5352293); V. DISCOVERY MR750W WITH GEM (5911000-3); W. MR 3.0T MR750 W (5352293); X. MR 3.0T MR750W GEM ENABLED (5911000-3, 5352293); Y. MR 3-0T MR750W (5911000-3); Z. MR DISCOVERY 750W GEM (5911000-3); AA. MR OPTIMA MR750W 3.0T (5911000-3); BB. MR750W (5911000-3); CC. MR750W GEM ENABLED (5911000-3, 5499460-7); DD. MR750W GEM ENABLED PLUS (5352293); EE. MR750W PGR 32-CHANNEL (5911000-3); FF. 3.0T MR750W GEM ENAB (5911000-3) Product Usage: The Discovery MR750w 3.0T system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR750w 3.0T system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance..

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems, LLC·October 3, 2018

    GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 30, 2014

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    Terumo Advanced Perfusion System 1-Level Sensor II Gel Pads Product Usage: Level sensor pads are used to attach the level sensors to a hard shell reservoir. includes coupling gel.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·March 22, 2017

    NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

    Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·March 25, 2015

    EXOGEN Ultrasound Coupling Gel

    FDA Enforcement
    Class II ·Terminated·Bioventus, LLC·January 20, 2021

    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·October 3, 2012

    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

    FDA Enforcement
    Class II ·Terminated·Integra Limited·October 3, 2012

    GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery MR750w equipped with the GEM option products. Affected devices are whole body magnetic resonance scanners indicated for use as a diagnostic imaging devices.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·May 7, 2014

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

    FDA Enforcement
    Class II ·Terminated·Mentor Texas, LP.·January 21, 2015

    NX3 Try-In Gel. The product is used as a tooth shade resin material.

    FDA Enforcement
    Class II ·Terminated·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·September 25, 2013

    BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·August 28, 2019

    Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL

    FDA Enforcement
    Class II ·Terminated·Helena Laboratories, Inc.·September 11, 2019

    Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359

    FDA Enforcement
    Class II ·Terminated·Exact Medical Manufacturing, Inc.·June 30, 2021