510(k) Final Decisions Rendered since June 01, 2026

510(k) Final Decisions Rendered since June 01, 2026 U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/510khome.html en-us Sun, 12 Jul 2026 09:49:18 GMT webo@cdrh.fda.gov http://www.fda.gov/graphics/mastheadart/centers/fda_mast_01.gif U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/ Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. 116 70 510(k) No: K260642 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260642 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261002 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261002 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260569 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260569 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261093 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261093 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253918 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253918 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261540 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261540 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260270 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260270 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260364 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260364 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260571 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260571 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253803 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253803 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252816 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252816 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253507 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253507 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252532 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252532 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252844 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252844 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253302 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253302 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253195 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253195 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252899 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252899 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261826 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261826 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261840 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261840 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261522 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261522 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K252854 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252854 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260116 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260116 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261530 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261530 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260780 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260780 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260726 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260726 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260373 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260373 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K252800 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252800 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261439 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261439 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253974 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253974 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K254034 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254034 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260703 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260703 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253124 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253124 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K252904 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252904 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261484 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261484 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260715 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260715 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260179 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260179 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260806 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260806 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260402 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260402 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253600 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253600 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253020 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253020 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260690 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260690 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253984 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253984 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260770 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260770 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253102 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253102 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260497 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260497 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253004 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253004 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K254209 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254209 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K252575 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252575 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K261510 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261510 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253553 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253553 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K261519 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261519 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253602 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253602 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253893 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253893 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253994 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253994 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260956 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260956 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253026 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253026 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260662 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260662 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253296 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253296 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K251684 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251684 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260754 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260754 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260289 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260289 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253204 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253204 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K261492 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261492 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260105 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260105 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260301 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260301 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260761 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260761 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253656 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253656 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K243192 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243192 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K254086 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254086 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253108 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253108 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253162 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253162 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260056 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260056 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K261402 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261402 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K253257 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253257 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K251944 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251944 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K261352 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261352 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K253066 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253066 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K260332 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260332 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K253542 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253542 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K251251 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251251 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260748 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260748 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K261806 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261806 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K252914 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252914 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260802 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260802 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K261549 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261549 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K253165 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253165 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260864 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260864 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260564 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260564 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K261621 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261621 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K253192 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253192 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K261329 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261329 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260855 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260855 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K254121 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254121 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K261016 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261016 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K253115 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253115 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K250690 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250690 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K261174 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261174 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260614 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260614 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260414 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260414 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260810 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260810 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K253919 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253919 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K253051 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253051 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K250129 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250129 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K250839 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250839 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260653 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260653 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K251326 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251326 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261251 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261251 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260710 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260710 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260859 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260859 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260174 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260174 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261610 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261610 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260322 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260322 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K253052 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253052 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K253650 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253650 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261292 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261292 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260849 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260849 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261256 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261256 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K254145 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254145 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261209 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261209 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K254087 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254087 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K253607 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253607 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K252932 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252932 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253688 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253688 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260406 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260406 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252963 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252963 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260514 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260514 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260935 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260935 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252937 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252937 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252933 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252933 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252987 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252987 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252996 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252996 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261213 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261213 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253088 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253088 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253196 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253196 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260635 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260635 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260346 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260346 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252323 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252323 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261204 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261204 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261366 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261366 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253437 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253437 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261634 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261634 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260102 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260102 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252171 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252171 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261207 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261207 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253015 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253015 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261175 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261175 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261604 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261604 Sat, 13 Jun 2026 04:00:00 GMT 510(k) No: K260300 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260300 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253151 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253151 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253172 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253172 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253825 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253825 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260333 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260333 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253121 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253121 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253922 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253922 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260482 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260482 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260885 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260885 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260036 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260036 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K261265 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261265 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253690 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253690 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260286 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260286 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K253059 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253059 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260126 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260126 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260452 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260452 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260335 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260335 Mon, 15 Jun 2026 04:00:00 GMT 510(k) No: K260693 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260693 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253069 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253069 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253374 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253374 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253137 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253137 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K260425 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260425 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253231 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253231 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253001 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253001 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K260958 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260958 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253723 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253723 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K261833 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261833 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K254025 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254025 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253264 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253264 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K260844 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260844 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253159 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253159 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K260899 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260899 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K253046 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253046 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K260831 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260831 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K261683 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261683 Tue, 16 Jun 2026 04:00:00 GMT 510(k) No: K261631 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261631 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K253155 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253155 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K260428 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260428 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K261570 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261570 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K261672 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261672 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K253255 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253255 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K260867 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260867 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K253634 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253634 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K252399 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252399 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K253333 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253333 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K260006 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260006 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K253055 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253055 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K261638 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261638 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K260916 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260916 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K260538 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260538 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K253045 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253045 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K261544 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261544 Wed, 17 Jun 2026 04:00:00 GMT 510(k) No: K250806 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250806 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: DEN250025 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250025 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K252982 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252982 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261707 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261707 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261099 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261099 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253521 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253521 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261713 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261713 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261246 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261246 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260946 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260946 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253131 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253131 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260729 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260729 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260280 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260280 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253050 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253050 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253824 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253824 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253187 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253187 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K251232 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251232 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261701 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261701 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261651 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261651 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K254169 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254169 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K261665 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261665 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260190 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260190 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253058 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253058 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260178 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260178 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K254254 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254254 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253126 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253126 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253678 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253678 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253110 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253110 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260636 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260636 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253080 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253080 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253116 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253116 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K251559 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251559 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260820 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260820 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K252066 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252066 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253776 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253776 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K253812 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253812 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K252839 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252839 Thu, 18 Jun 2026 04:00:00 GMT 510(k) No: K260369 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260369 Sat, 20 Jun 2026 04:00:00 GMT 510(k) No: K253176 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253176 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K260316 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260316 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K261075 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261075 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K261076 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261076 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K261950 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261950 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K254011 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254011 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K254287 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254287 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K261279 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261279 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K261342 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261342 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K253421 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253421 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K253148 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253148 Mon, 22 Jun 2026 04:00:00 GMT 510(k) No: K253199 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253199 Tue, 23 Jun 2026 04:00:00 GMT 510(k) No: K261004 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261004 Tue, 23 Jun 2026 04:00:00 GMT 510(k) No: K253180 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253180 Tue, 23 Jun 2026 04:00:00 GMT 510(k) No: K253211 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253211 Tue, 23 Jun 2026 04:00:00 GMT 510(k) No: K260669 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260669 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K260998 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260998 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K253263 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253263 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K253560 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253560 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K253393 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253393 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K260394 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260394 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K253404 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253404 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K261866 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261866 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K261260 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261260 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K260937 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260937 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K251929 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251929 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K261023 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261023 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K261055 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261055 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K261772 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261772 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K252117 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252117 Wed, 24 Jun 2026 04:00:00 GMT 510(k) No: K253216 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253216 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K260231 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260231 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K260809 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260809 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K260790 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260790 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K260480 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260480 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K261458 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261458 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253394 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253394 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K254108 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254108 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253274 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253274 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K260709 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260709 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K260992 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260992 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K261242 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261242 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253367 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253367 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253384 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253384 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253330 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253330 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K261025 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261025 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253786 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253786 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K251188 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251188 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K253386 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253386 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K252584 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252584 Thu, 25 Jun 2026 04:00:00 GMT 510(k) No: K261039 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261039 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K260018 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260018 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K260061 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260061 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K253306 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253306 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K261351 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261351 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K261442 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261442 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K254232 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254232 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K261745 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261745 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K253316 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253316 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K250070 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250070 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K260412 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260412 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K253921 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253921 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K261455 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261455 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K260714 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260714 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K261253 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261253 Fri, 26 Jun 2026 04:00:00 GMT 510(k) No: K253390 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253390 Sat, 27 Jun 2026 04:00:00 GMT 510(k) No: K261122 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261122 Sat, 27 Jun 2026 04:00:00 GMT 510(k) No: K253301 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253301 Sat, 27 Jun 2026 04:00:00 GMT 510(k) No: K253969 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253969 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K253628 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253628 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K260918 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260918 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K253484 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253484 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K261052 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261052 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K261415 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261415 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K261461 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261461 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K251492 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251492 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K260667 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260667 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K254149 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254149 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K261481 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261481 Mon, 29 Jun 2026 04:00:00 GMT 510(k) No: K261101 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261101 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K261119 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261119 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K260576 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260576 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K261808 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261808 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K261068 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261068 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K253767 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253767 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K262195 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K262195 Tue, 30 Jun 2026 04:00:00 GMT 510(k) No: K253434 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253434 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K252483 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252483 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K253527 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253527 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261474 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261474 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261485 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261485 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261147 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261147 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K254056 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254056 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261852 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261852 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K260556 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260556 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K253802 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253802 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K253420 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253420 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261054 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261054 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261889 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261889 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261473 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261473 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K262228 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K262228 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261021 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261021 Wed, 01 Jul 2026 04:00:00 GMT 510(k) No: K261825 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261825 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K261847 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261847 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K260527 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260527 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K261587 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261587 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K261867 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261867 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: DEN250034 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250034 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K252463 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252463 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K261880 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261880 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K253704 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253704 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K253463 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253463 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K253884 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253884 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K261897 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261897 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K260528 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260528 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K260755 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260755 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K261129 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261129 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K252243 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252243 Thu, 02 Jul 2026 04:00:00 GMT 510(k) No: K260596 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260596 Thu, 02 Jul 2026 04:00:00 GMT