| K253468 — Nova Eye iTrack 250A Canaloplasty Microcatheter (iTrack 250A) | Nova Eye, Inc. Aug 10, 2026 |
| K261576 — Icona Hip Stem | Corin, Ltd. Aug 10, 2026 |
| K253528 — Atellica IM CA 19-9 II | Siemens Healthcare Diagnostics, Inc. Aug 10, 2026 |
| K254036 — Novii+ Wireless Patch System | Datex Ohmeda, Inc. Aug 10, 2026 |
| K262427 — Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. Aug 10, 2026 |
| K260094 — Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Aug 10, 2026 |
| K261602 — Eye Recovery Pro (PH-e03) | Shenzhen Goodwind Technology Development Co., Ltd. Aug 10, 2026 |
| K260165 — Unimpregnated Central Venous Catheter | Spectrum Vascular Aug 10, 2026 |
| K254069 — Hemoclip (511 series, 543 series) | Hangzhou AGS MedTech Co., Ltd. Aug 10, 2026 |
| K253505 — Zamenix P | Roen Surgical, Inc. Aug 7, 2026 |
| K262357 — Arthrex Bioabsorbable PushLock Suture Anchors | Arthrex, Inc. Aug 7, 2026 |
| K253561 — Aperio iQC DX Software | Leica Biosystems Imaging, Inc. Aug 7, 2026 |
| K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) | Shenzhen Chuangtong Yigou Technology Co., Ltd. Aug 7, 2026 |
| K260933 — Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Aug 7, 2026 |
| K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000) | Intuitive Surgical, Inc. Aug 7, 2026 |
| K253453 — Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. Aug 7, 2026 |
| K260567 — EW10-EC02 Endoscopy Support Program | Fujifilm Corporation Aug 7, 2026 |
| K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. Aug 7, 2026 |
| K261563 — Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. Aug 7, 2026 |
| K261937 — PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak Aug 7, 2026 |
| K261437 — Mistral-Air® Warming System | The Surgical Company International B.V., Doing Business As TSC Life Aug 7, 2026 |
| K261362 — Xpert Hemorrhagic Fever | Cepheid Aug 7, 2026 |
| K261905 — BUM Oil | Bumlicious, LLC (DBA Bumlicious) Aug 7, 2026 |
| K254205 — Zenition 30 | Philips Medical Systems Nederland B.V. Aug 7, 2026 |
| K253554 — Aperio GT 450 DX; Aperio GT 180 DX | Leica Biosystems Imaging, Inc. Aug 7, 2026 |
| K252571 — mdprostate | Mediaire GmbH Aug 7, 2026 |
| K261668 — Venue Go | GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC Aug 7, 2026 |
| K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. Aug 7, 2026 |
| K261059 — Overjet Multi-Image Caries and Charting Assist | Overjet, Inc. Aug 6, 2026 |
| K253469 — Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) | Mozarc Medical Us, LLC Aug 6, 2026 |
| K251508 — Telemetry Monitor (iT30, iT50) | Edan Instruments, Inc. Aug 6, 2026 |
| K261121 — Megalodon Dynamic Compression System | Paragon 28, Inc. Aug 6, 2026 |
| K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. Dba Stryker Orthopaedics Aug 6, 2026 |
| K253999 — Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB Aug 6, 2026 |
| K261571 — Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Aug 6, 2026 |
| K260223 — Aristotle Mini Guidewire | Scientia Vascular, Inc. Aug 6, 2026 |
| K254194 — QIAstat-Dx BCID GPF Plus AMR Panel | QIAGEN GmbH Aug 6, 2026 |
| K253858 — GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. Aug 5, 2026 |
| K261380 — Concentriq AP-Dx | Proscia, Inc. Aug 5, 2026 |
| K252853 — CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. Aug 5, 2026 |
| K260120 — NaturaJel Oral Wound Care Kit | HCS Innovation, LLC Aug 5, 2026 |
| K254211 — pVasc Net Mechanical Thrombectomy Device | Vesalio, Inc. Aug 5, 2026 |
| K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical , Ltd. Aug 5, 2026 |
| K260845 — Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. Aug 5, 2026 |
| K262056 — Rusch Latex Gold Foley Catheter | Teleflex Medical Sdn. Bhd. Aug 5, 2026 |
| K261932 — Leksell® Vantage Stereotactic System | Elekta Solutions AB Aug 5, 2026 |
| K261456 — Ruthinium Disc | Dental Manufacturing S.P.A. Aug 5, 2026 |
| K260737 — Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). | Convatec Aug 5, 2026 |
| K261851 — LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10) | Shenzhen Qianyu Technology Co., Ltd. Aug 4, 2026 |
| K261496 — LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited Aug 4, 2026 |