| K252648 — Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. Mar 13, 2026 |
| K254277 — Embrace Neonatal MRI System | Aspect Imaging, Ltd. Mar 13, 2026 |
| K254059 — Access anti-HBc IgM | Beckman Coulter, Inc. Mar 13, 2026 |
| K253732 — Permatage Flowable, Settable Bone Paste | Orthocon, Inc. Mar 13, 2026 |
| K251848 — Pentacam® Cornea OCT | Oculus Optikgeräte GmbH Mar 13, 2026 |
| K251916 — GenBody COVID-19 Ag Home Test | Genbody.Inc. Mar 13, 2026 |
| K260455 — New Wave System | Zeto, Inc. Mar 13, 2026 |
| K250655 — Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA Mar 12, 2026 |
| K252089 — Tyto Stethoscope (G3) | Tyto Care , Ltd. Mar 12, 2026 |
| K252546 — VantageTM Lumbar Decompression Kit | Allevion Medical, LLC Mar 12, 2026 |
| K251888 — VPAP Pediatric Face Mask | Hsiner Co., Ltd. Mar 12, 2026 |
| K253062 — Tigertriever 25 Revascularization Device | Rapid Medical Ltd. Mar 12, 2026 |
| K260502 — Liv Pre-lubricated Intermittent Catheter | HR Healthcare Mar 12, 2026 |
| K254233 — MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG Mar 12, 2026 |
| K253936 — Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. Mar 12, 2026 |
| K253525 — Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. Mar 12, 2026 |
| K253429 — Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. Mar 12, 2026 |
| K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220) | A Cute Baby, Inc. Mar 12, 2026 |
| K253636 — Zionic Pro Max (EMS) | Termosalud S.L. Mar 12, 2026 |
| K252401 — implaFit® short stems | Implantcast GmbH Mar 12, 2026 |
| K251584 — Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. Mar 12, 2026 |
| K250794 — InVera Infusion Device | Invera Medical Mar 12, 2026 |
| K251964 — Mimics Thoracic Planner | Materialise NV Mar 12, 2026 |
| K253566 — Affixus Retrograde Femoral Nailing System | Zimmer, Inc. Mar 12, 2026 |
| K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. Mar 12, 2026 |
| K251750 — Trax EX Anchor | Trax Surgical, Inc. Mar 12, 2026 |
| K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) | Bionit Labs Srl Mar 12, 2026 |
| K253743 — MiniMed Flex pump | Medtronic Minimed, Inc. Mar 12, 2026 |
| K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. Mar 12, 2026 |
| K254040 — LungFlow Basket Catheter | Free Flow Medical, Inc. Mar 12, 2026 |
| K252110 — Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. Mar 12, 2026 |
| K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. Mar 12, 2026 |
| K253734 — Taurus Clip | Taurus Endoscopy Mar 12, 2026 |
| K253986 — da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. Mar 11, 2026 |
| K254197 — Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. Mar 11, 2026 |
| K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Carestream Health Mar 11, 2026 |
| K254047 — Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) | Shenzhen Chuangtong Yigou Technology Co., Ltd. Mar 11, 2026 |
| K253693 — Strut Suture; No-Tie Button | Riverpoint Medical, LLC Mar 11, 2026 |
| K253624 — INHANCE Reverse Shoulder System | Depuy Ireland UC Mar 11, 2026 |
| K253906 — Xpert Hand | Newclip Technics Mar 11, 2026 |
| K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC Mar 11, 2026 |
| K252028 — LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. Mar 11, 2026 |
| K250937 — Venous Return Cannulae | LivaNova USA, Inc. Mar 11, 2026 |
| K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation Mar 10, 2026 |
| K260773 — Varios Combi Pro2 | Nakanishi, Inc. Mar 10, 2026 |
| K253517 — Reselute Tibial Nail | Reselute, Inc. Mar 10, 2026 |
| K252353 — myray ProXIma X6 | Cefla S.C. Mar 10, 2026 |
| K260765 — Gemini NOVA 810+980 Soft Tissue Laser | Azena Medical, LLC Mar 10, 2026 |
| K260595 — Sonosite iLOOK Ultrasound System | FUJIFILM Sonosite, Inc. Mar 10, 2026 |
| K254093 — DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System | Synthes GmbH Mar 10, 2026 |