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    Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 15, 2012

    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

    Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Round Mod 10888628001220, NATRELLE Style 10-270 Gel Round Mod 10888628001237, NATRELLE Style 10-300 Gel Round Mod 10888628001244, NATRELLE Style 10-330 Gel Round Mod 10888628001251, NATRELLE Style 10-360 Gel Round Mod 10888628001268, NATRELLE Style 10-390 Gel Round Mod 10888628001275, NATRELLE Style 10-420 Gel Round Mod 10888628001282, NATRELLE Style 10-450 Gel Round Mod 10888628001299, NATRELLE Style 10-510 Gel Round Mod 10888628001312, NATRELLE Style 10-800 Gel Round Mod 10888628001374, Style 15/UDI: NATRELLE Style 15-158 Gel Round Mod Plus 10888628001381, NATRELLE Style 15-176 Gel Round Mod Plus 10888628001398, NATRELLE Style 15-194 Gel Round Mod Plus 10888628001404, NATRELLE Style 15-213 Gel Round Mod Plus 10888628001411, NATRELLE Style 15-234 Gel Round Mod Plus 10888628001428, NATRELLE Style 15-265 Gel Round Mod Plus 10888628001435, NATRELLE Style 15-286 Gel Round Mod Plus 10888628001442, NATRELLE Style 15-304 Gel Round Mod Plus 10888628001459, NATRELLE Style 15-339 Gel Round Mod Plus 10888628001466, NATRELLE Style 15-371 Gel Round Mod Plus 10888628001473, NATRELLE Style 15-397 Gel Round Mod Plus 10888628001480, NATRELLE Style 15-421 Gel Round Mod Plus 10888628001497, NATRELLE Style 15-457 Gel Round Mod Plus 10888628001503, NATRELLE Style 15-492 Gel Round Mod Plus 10888628001510, NATRELLE Style 15-533 Gel Round Mod Plus 10888628001527, NATRELLE Style 15-575 Gel Round Mod Plus 10888628001534, NATRELLE Style 15-616 Gel Round Mod Plus 10888628001541, NATRELLE Style 15-659 Gel Round Mod Plus 10888628001558, NATRELLE Style 15-700 Gel Round Mod Plus 10888628001565, NATRELLE Style 15-752 Gel Round Mod Plus 10888628001572, Style 20/UDI: NATRELLE Style 20-230 Gel Round High 10888628001633, NATRELLE Style 20-280 Gel Round High 10888628001657, NATRELLE Style 20-300 Gel Round High 10888628001664, NATRELLE Style 20-325 Gel Round High 10888628001671, NATRELLE Style 20-350 Gel Round High 10888628001688, NATRELLE Style 20-375 Gel Round High 10888628001695, NATRELLE Style 20-400 Gel Round High 10888628001701, NATRELLE Style 20-425 Gel Round High 10888628001718, NATRELLE Style 20-450 Gel Round High 10888628001725, NATRELLE Style 20-475 Gel Round High 10888628001732, NATRELLE Style 20-500 Gel Round High 10888628001749, NATRELLE Style 20-550 Gel Round High 10888628001756, NATRELLE Style 20-600 Gel Round High 10888628001763, NATRELLE Style 20-650 Gel Round High 10888628001770, NATRELLE Style 20-700 Gel Round High 10888628001787, NATRELLE Style 20-750 Gel Round High 10888628001794, NATRELLE Style 20-800 Gel Round High 10888628001800, Style 40/UDI: NATRELLE Style 40-160 Gel Round Mod 10888628001855, NATRELLE Style 40-240 Gel Round Mod 10888628001893, NATRELLE Style 40-340 Gel Round Mod 10888628001947, Style 45/UDI: NATRELLE Style 45-120 Gel Round Extra High 10888628002005, NATRELLE Style 45-160 Gel Round Extra High 10888628002012, NATRELLE Style 45-240 Gel Round Extra High 10888628002036, NATRELLE Style 45-280 Gel Round Extra High 10888628002043, NATRELLE Style 45-320 Gel Round Extra High 10888628002050, NATRELLE Style 45-360 Gel Round Extra High 10888628002067, NATRELLE Style 45-400 Gel Round Extra High 10888628002074, NATRELLE Style 45-460 Gel Round Extra High 10888628002081, NATRELLE Style 45-500 Gel Round Extra High 10888628002098, NATRELLE Style 45-550 Gel Round Extra High 10888628002104, NATRELLE Style 45-600 Gel Round Extra High 10888628002111, NATRELLE Style 45-650 Gel Round Extra High 10888628002128, NATRELLE Style 45-700 Gel Round Extra High 10888628002135, NATRELLE Style 45-800 Gel Round Extra High 10888628002142,

    FDA Enforcement
    Class III ·Terminated·Allergan PLC·December 25, 2019

    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

    NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (Soft Touch Gel), Inspira ST F (Soft Touch Gel), Inspira ST X (Soft Touch Gel) Style 10/UDI: NATRELLE Sty 10-360 Rstrl Sizer Gel Mod 10888628005587 NATRELLE Sty 10-390 Rstrl Sizer Gel Mod 10888628005594 NATRELLE Sty 10-420 Rstrl Sizer Gel Mod 10888628005600 NATRELLE Sty 10-450 Rstrl Sizer Gel Mod 10888628005617 NATRELLE Sty 10-480 Rstrl Sizer Gel Mod 10888628005624 NATRELLE Sty 10-510 Rstrl Sizer Gel Mod 10888628005631 NATRELLE Sty 10-700 Rstrl Sizer Gel Mod 10888628005679 NATRELLE Sty 10-750 Rstrl Sizer Gel Mod 10888628005686 NATRELLE Sty 10-800 Rstrl Sizer Gel Mod 10888628005693 Style 15/UDI: NATRELLE Sty 15-304 Rstrl Sizer Gel Mid 10888628005778 NATRELLE Sty 15-339 Rstrl Sizer Gel Mid 10888628005785 NATRELLE Sty 15-371 Rstrl Sizer Gel Mid 10888628005792 NATRELLE Sty 15-397 Rstrl Sizer Gel Mid 10888628005808 NATRELLE Sty 15-421 Rstrl Sizer Gel Mid 10888628005815 NATRELLE Sty 15-457 Rstrl Sizer Gel Mid 10888628005822 NATRELLE Sty 15-492 Rstrl Sizer Gel Mid 10888628005839 NATRELLE Sty 15-533 Rstrl Sizer Gel Mid 10888628005846 NATRELLE Sty 15-575 Rstrl Sizer Gel Mid 10888628005853 NATRELLE Sty 15-616 Rstrl Sizer Gel Mid 10888628005860 Style 20/UDI: NATRELLE Sty 20-350 Rstrl Sizer Gel High 10888628006003 NATRELLE Sty 20-700 Rstrl Sizer Gel High 10888628006102 NATRELLE Sty 20-750 Rstrl Sizer Gel High 10888628006119 Inspira X (responsive Gel)/UDI: Natrelle Inspira X-Full 205cc Sizer (US) 10888628009431 Natrelle Inspira X-Full 225cc Sizer (US) 10888628009448 Natrelle Inspira X-Full 255cc Sizer (US) 10888628009455 Natrelle Inspira X-Full 285cc Sizer (US) 10888628009462 Natrelle Inspira X-Full 310cc Sizer (US) 10888628009479 Natrelle Inspira X-Full 340cc Sizer (US) 10888628009486 Natrelle Inspira X-Full 375cc Sizer (US) 10888628009493 Natrelle Inspira X-Full 400cc Sizer (US) 10888628009509 Natrelle Inspira X-Full 420cc Sizer (US) 10888628009516 Natrelle Inspira X-Full 445cc Sizer (US) 10888628009523 Natrelle Inspira X-Full 470cc Sizer (US) 10888628009530 Natrelle Inspira X-Full 495cc Sizer (US) 10888628009547 Natrelle Inspira X-Full 525cc Sizer (US) 10888628009554 Natrelle Inspira X-Full 545cc Sizer (US) 10888628009561 Natrelle Inspira X-Full 560cc Sizer (US) 10888628009578 Natrelle Inspira X-Full 580cc Sizer (US) 10888628009585 Natrelle Inspira X-Full 615cc Sizer (US) 10888628009592 Natrelle Inspira X-Full 650cc Sizer (US) 10888628009608 Natrelle Inspira X-Full 700cc Sizer (US) 10888628009615 Natrelle Inspira X-Full 750cc Sizer (US) 10888628009622 Natrelle Inspira X-Full 800cc Sizer (US) 10888628009639 Inspira F (responsive Gel)/UDI: MSZ-F180 Natrelle Inspira FullProf 180cc Sizer US 10888628009226 MSZ-F200 Natrelle Inspira FullProf 200cc Sizer US 10888628009233 MSZ-F220 Natrelle Inspira FullProf 220cc Sizer US 10888628009240 MSZ-F240 Natrelle Inspira FullProf 240cc Sizer US 10888628009257 MSZ-F265 Natrelle Inspira FullProf 265cc Sizer US 10888628009264 MSZ-F295 Natrelle Inspira FullProf 295cc Sizer US 10888628009271 MSZ-F325 Natrelle Inspira FullProf 325cc Sizer US 10888628009288 MSZ-F335 Natrelle Inspira FullProf 335cc Sizer US 10888628009295 MSZ-F345 Natrelle Inspira FullProf 345cc Sizer US 10888628009301 MSZ-F365 Natrelle Inspira FullProf 365cc Sizer US 10888628009318 MSZ-F385 Natrelle Inspira FullProf 385cc Sizer US 10888628009325 MSZ-F415 Natrelle Inspira FullProf 415cc Sizer US 10888628009332 MSZ-F450 Natrelle Inspira FullProf 450cc Sizer US 10888628009349 MSZ-F485 Natrelle Inspira FullProf 485cc Sizer US 10888628009356 MSZ-F520 Natrelle Inspira FullProf 520cc Sizer US 10888628009363 MSZ-F560 Natrelle Inspira FullProf 560cc Sizer US 10888628009370 MSZ-F605 Natrelle

    FDA Enforcement
    Class III ·Terminated·Allergan PLC·December 25, 2019

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

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

    IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

    FDA Enforcement
    Class I ·Terminated·Wellspring Pharmaceutical Corporation·August 6, 2014

    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

    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the identification of alkaline Phosphatase isoenzymes by electrophoresis.

    FDA Enforcement
    Class III ·Terminated·Helena Laboratories, Inc.·December 12, 2018

    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

    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

    FDA Enforcement
    Class I ·Terminated·Lumenis, Inc.·November 10, 2021

    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

    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.

    FDA Enforcement
    Class I ·Terminated·Childrens Medical Ventures·August 27, 2014