BEUDAMED
    9 results · 8ms · Sources: EU EUDAMED, US FDA

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    Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372

    FDA Enforcement
    Class II ·Ongoing·Cook Biotech, Inc.·October 2, 2024

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    FDA Enforcement
    Class II ·Ongoing·Diagnostica Stago, Inc.·March 25, 2026

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 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