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    StageOne™ Select Hip Cement Spacer Molds

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657006552·Weil Blakesley Forceps, size 01, 45 degree, 3 x...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111191435·REYNOLDS SCISS NAR TIP CVD 6

    MILLENNIUM MICROSURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    SEPRAFILM (SODIUM HYALURONATE, CARBOXYMETHYLCELLULOSE) MEMBRANE

    FDA Adverse Event
    GENZYME BIOSURGERY (SEPRAFILM/PACK)·Product code MCN·August 2, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014

    IMMERSION HYDROBATH

    FDA Adverse Event
    Malfunction ·INVACARE CLEVELAND STREET·Product code ILJ·July 12, 2013

    Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945 CP102946 CP102947 CP102948 CP112662 CP112663 CP112664 CP112674 CP112675 CP113771 CP113777 CP113778 CP113782 CP113783 CP114083 CP114090 CP114112 CP114118 CP114148 CP114213 CP114388 CP114436 CP114463 CP114472 CP114478 CP114495 CP114532 CP114561 CP114563 CP114605 CP114695 CP114756 CP114782 CP114783 CP114933 CP114987 CP115008 CP115048 CP115049 CP115050 CP115166 CP115209 CP115212 CP115312 CP115313 CP115314 CP115318 CP115319 CP115320 CP115322 CP115357 CP115358 CP115359 CP115360 CP115362 CP115363 CP115371 CP161304 CP161305 CP161306 CP161307 CP161522 CP161560 CP161735 CP161741 CP161751 CP161752 CP161753 CP161768 CP161793 CP161795 CP161831 CP161867 CP162006 CP162007 CP162008 CP162013 CP162017 CP162042 CP162043 CP162055 CP162084 CP162085 CP162086 CP162121 CP162149 CP162150 PM0000711 PM103016 PM103022 PM103060 PM155537 PM155577 PM155578 PM155580 PM155590 PM155591 PM155592 PM155594 PM155595 PM155602 PM155603 PM155604 PM155610 PM155612 PM155615 PM155616 PM155618 PM155623 PM155630 PM155635 PM155638 PM155640 PM155641 PM155643 PM155644 PM155646 PM155650 PM155653 PM155654 PM155656 PM155660 PM155662 PM155663 PM155677 PM155678 PM155685 PM155686 PM155687 PM155694 PM155698 PM155702 PM155710 PM155711 PM155712 PM155715 PM155717 PM155724 PM155725 PM155727 PM155728 PM155730 PM155734 PM155737 PM155738 PM155742 PM155746 PM155750 PM155751 PM155753 PM155756 PM155757 PM155761 PM155762 PM155767 PM155771 PM155774 PM155780 PM155781 PM155785 PM155789 PM155791 PM155792 PM155793 PM155795 PM155804 PM155806 PM155808 PM155809 PM155812 PM155813 PM155815 PM155818 PM155820 PM155823 PM155825 PM155828 PM155829 PM155840 PM155841 PM155842 PM155843 PM155847 PM155849 PM155850 PM155854 PM155857 PM155860 PM155863 PM155867 PM155868 PM155871 PM155872 PM155879 PM155882 PM155887 PM155888 PM155890 PM155892 PM155893 PM155894 PM155895 PM155897 PM155903 PM155905 PM155909 PM155913 PM155922 PM155926 PM155927 PM155928 PM155929 PM155933 PM155938 PM155939 PM155940 PM155942 PM155945 PM155947 PM155948 PM155950 PM155952 PM155963 PM155965 PM155972 PM155974 PM155979 PM155982 PM155983 PM155986 PM155988 PM155989 PM155991 PM155993 PM155997 PM155998 PM156000 PM156002 PM156007 PM156008 PM156012 PM156035 PM156038 PM156039 PM156041 PM156043 PM156044 PM156047 PM156048 PM156060 PM156061 PM156072 PM156079 PM156085 PM156092 PM156095 PM156101 PM156104 PM156110 PM156116 PM156132 PM156133 PM156143 PM156147 PM156154 PM156165 PM156166 PM156173 PM156184 PM156188 PM156192 PM156193 PM156197 PM156205 PM156207 PM156219 PM156235 PM156236 PM156244 PM156248 PM156254 PM156266 PM156275 PM156280 PM156281 PM156290 PM156292 PM156293 PM156320 PM156329 PM156340 PM156343 PM156345 PM156351 PM156352 PM156356 PM156357 PM156358 PM156362 PM156377 PM156379 PM156382 PM156384 PM156387 PM156388 PM156390 PM156391 PM156392 PM156393 PM156397 PM156402 PM156403 PM156405 PM156406 PM156409 PM156410 PM156431 PM156434 PM156435 PM156438 PM156444 PM156448 PM156453 PM156457 PM156458 PM156460 PM156477 PM156485 PM156489 PM156492 PM156497 PM156501 PM156510 PM156511 PM156520 PM156529 PM156532 PM156533 PM156539 PM156544 PM156546 PM156551 PM156560 PM156561 PM156563 PM156565 PM156567 PM156570 PM156572 PM156573 PM156578 PM156584 PM156589 PM156595 PM156596 PM156604 PM156605 PM156609 PM156610 PM156620 PM156632 PM156641 PM156643 PM156656 PM156663 PM156666 PM156668 PM156674 PM156675 PM156676 PM156680 PM156681 PM156682 PM156684 PM156688 PM156691 PM156692 PM156693 PM156698 PM156700 PM156704 PM156705 PM156713 PM156718 PM156803 PM156814 PM156821 PM156829 PM156830 PM156831 PM156834 PM15

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

    Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 10888628032835, Natrelle Inspira SSM 175cc BI (US) 10888628032842, Natrelle Inspira SSM 195cc BI (US) 10888628032859, Natrelle Inspira SSM 210cc BI (US) 10888628032866, Natrelle Inspira SSM 240cc BI (US) 10888628032873, Natrelle Inspira SSM 255cc BI (US) 10888628032880, Natrelle Inspira SSM 275cc BI (US) 10888628032897, Natrelle Inspira SSM 295cc BI (US) 10888628032903, Natrelle Inspira SSM 310cc BI (US) 10888628032910, Natrelle Inspira SSM 330cc BI (US) 10888628032927, Natrelle Inspira SSM 345cc BI (US) 10888628032934, Natrelle Inspira SSM 360cc BI (US) 10888628032941, Natrelle Inspira SSM 375cc BI (US) 10888628032958, Natrelle Inspira SSM 405cc BI (US) 10888628032965, Natrelle Inspira SSM 445cc BI (US) 10888628032972, Natrelle Inspira SSM 485cc BI (US) 10888628032989, Natrelle Inspira SSM 520cc BI (US) 10888628032996, Natrelle Inspira SSM 560cc BI (US) 10888628033009, Natrelle Inspira SSM 600cc BI (US) 10888628033016, Natrelle Inspira SSM 640cc BI (US) 10888628033023, Natrelle Inspira SSM 685cc BI (US) 10888628033030, 7608 SSF/UDI: Natrelle Inspira SSF 180cc BI (US) 10888628033054, Natrelle Inspira SSF 200cc BI (US) 10888628033061, Natrelle Inspira SSF 220cc BI (US) 10888628033078, Natrelle Inspira SSF 240cc BI (US) 10888628033085, Natrelle Inspira SSF 265cc BI (US) 10888628033092, Natrelle Inspira SSF 295cc BI (US) 10888628033108, Natrelle Inspira SSF 325cc BI (US) 10888628033115, Natrelle Inspira SSF 335cc BI (US) 10888628033122, Natrelle Inspira SSF 345cc BI (US) 10888628033139, Natrelle Inspira SSF 365cc BI (US) 10888628033146, Natrelle Inspira SSF 385cc BI (US) 10888628033153, Natrelle Inspira SSF 415cc BI (US) 10888628033160, Natrelle Inspira SSF 450cc BI (US) 10888628033177, Natrelle Inspira SSF 485cc BI (US) 10888628033184, Natrelle Inspira SSF 520cc BI (US) 10888628033191, Natrelle Inspira SSF 560cc BI (US) 10888628033207, Natrelle Inspira SSF 605cc BI (US) 10888628033214, Natrelle Inspira SSF 650cc BI (US) 10888628033221, Natrelle Inspira SSF 695cc BI (US) 10888628033238, Natrelle Inspira SSF 745cc BI (US) 10888628033245, Natrelle Inspira SSF 770cc BI (US) 10888628033252, 7609 SSX/UDI: Natrelle Inspira SSX 200cc BI (US) 10888628033269, Natrelle Inspira SSX 225cc BI (US) 10888628033276, Natrelle Inspira SSX 255cc BI (US) 10888628033283, Natrelle Inspira SSX 285cc BI (US) 10888628033290, Natrelle Inspira SSX 310cc BI (US) 10888628033306, Natrelle Inspira SSX 340cc BI (US) 10888628033313, Natrelle Inspira SSX 375cc BI (US) 10888628033320, Natrelle Inspira SSX 400cc BI (US) 10888628033337, Natrelle Inspira SSX 420cc BI (US) 10888628033344, Natrelle Inspira SSX 445cc BI (US) 10888628033351, Natrelle Inspira SSX 470cc BI (US) 10888628033368, Natrelle Inspira SSX 495cc BI (US) 10888628033375, Natrelle Inspira SSX 525cc BI (US) 10888628033382, Natrelle Inspira SSX 545cc BI (US) 10888628033399, Natrelle Inspira SSX 560cc BI (US) 10888628033405, Natrelle Inspira SSX 580cc BI (US) 10888628033412, Natrelle Inspira SSX 615cc BI (US) 10888628033429, Natrelle Inspira SSX 650cc BI (US) 10888628033436, Natrelle Inspira SSX 700cc BI (US) 10888628033443, Natrelle Inspira SSX 750cc BI (US) 10888628033450, Natrelle Inspira SSX 800cc BI (US) 10888628033467, 7513 SRL/UDI: Natrelle Inspira SRL 110cc BI (US) 10888628006645, Natrelle Inspira SRL 125cc BI (US) 10888628006652, Natrelle Inspira SRL 140cc BI (US) 10888628006669, Natrelle Inspira SRL 170cc BI (US) 10888628006676, Natrelle Inspira SRL 200cc BI (US) 10888628006683, Natrelle Inspira SRL 230cc BI (US) 10888628006690, Natrelle Inspira SRL 260cc BI (US) 10888628006706, Natrelle Inspira SRL 290cc BI (US) 10888628006713, Natrelle Inspira SR

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

    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

    Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537, NATRELLE Style 68LP-200 Saline Round Low 10888628000544, NATRELLE Style 68LP-225 Saline Round Low 10888628000551, NATRELLE Style 68LP-250 Saline Round Low 10888628000568, NATRELLE Style 68LP-275 Saline Round Low 10888628000575, NATRELLE Style 68LP-300 Saline Round Low 10888628000582, NATRELLE Style 68LP-325 Saline Round Low 10888628000599, NATRELLE Style 68LP-350 Saline Round Low 10888628000605, NATRELLE Style 68LP-400 Saline Round Low 10888628000612, NATRELLE Style 68LP-420 Saline Round Low 10888628000629, NATRELLE Style 68LP-440 Saline Round Low 10888628000636, NATRELLE Style 68LP-480 Saline Round Low 10888628000643, NATRELLE Style 68LP-525 Saline Round Low 10888628000650, NATRELLE Style 68LP-550 Saline Round Low 10888628000667, NATRELLE Style 68LP-600 Saline Round Low 10888628000674, NATRELLE Style 68LP-640 Saline Round Low 10888628000681, NATRELLE Style 68LP-680 Saline Round Low 10888628000698, Style 68 HP/UDI: NATRELLE Style 68HP-160 Saline Round High 10888628000353, NATRELLE Style 68HP-200 Saline Round High 10888628000360, NATRELLE Style 68HP-240 Saline Round High 10888628000377, NATRELLE Style 68HP-280 Saline Round High 10888628000384, NATRELLE Style 68HP-320 Saline Round High 10888628000391, NATRELLE Style 68HP-350 Saline Round High 10888628000407, NATRELLE Style 68HP-400 Saline Round High 10888628000414, NATRELLE Style 68HP-425 Saline Round High 10888628000421, NATRELLE Style 68HP-465 Saline Round High 10888628000438, NATRELLE Style 68HP-500 Saline Round High 10888628000445, NATRELLE Style 68HP-550 Saline Round High 10888628000452, NATRELLE Style 68HP-600 Saline Round High 10888628000469, NATRELLE Style 68HP-650 Saline Round High 10888628000476, NATRELLE Style 68HP-700 Saline Round High 10888628000483, NATRELLE Style 68HP-750 Saline Round High 10888628000490, NATRELLE Style 68HP-800 Saline Round High 10888628000506, Style 68 MP/UDI: NATRELLE Style 68MP-120 Saline Round Mod 10888628000155, NATRELLE Style 68MP-150 Saline Round Mod 10888628000162, NATRELLE Style 68MP-180 Saline Round Mod 10888628000179, NATRELLE Style 68MP-210 Saline Round Mod 10888628000186, NATRELLE Style 68MP-240 Saline Round Mod 10888628000193, NATRELLE Style 68MP-270 Saline Round Mod 10888628000209, NATRELLE Style 68MP-300 Saline Round Mod 10888628000216, NATRELLE Style 68MP-330 Saline Round Mod 10888628000223, NATRELLE Style 68MP-360 Saline Round Mod 10888628000230, NATRELLE Style 68MP-390 Saline Round Mod 10888628000247, NATRELLE Style 68MP-420 Saline Round Mod 10888628000254, NATRELLE Style 68MP-450 Saline Round Mod 10888628000261, NATRELLE Style 68MP-480 Saline Round Mod 10888628000278, NATRELLE Style 68MP-510 Saline Round Mod 10888628000285, NATRELLE Style 68MP-550 Saline Round Mod 10888628000292, NATRELLE Style 68MP-600 Saline Round Mod 10888628000308, NATRELLE Style 68MP-650 Saline Round Mod 10888628000315, NATRELLE Style 68MP-700 Saline Round Mod 10888628000322, NATRELLE Style 68MP-750 Saline Round Mod 10888628000339, NATRELLE Style 68MP-800 Saline Round Mod 10888628000346,

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

    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

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025