| K252145 — GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC Dec 23, 2025 |
| K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Shenzhen Siken 3D Technology Development Co., Ltd. Dec 23, 2025 |
| K253727 — Syndesmosis TightRope PRO | Arthrex, Inc. Dec 22, 2025 |
| K252611 — aprevo® cervical plating system | Carlsmed, Inc. Dec 22, 2025 |
| K253664 — SKOUT system | Iterative Health Dec 22, 2025 |
| K251105 — Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation Dec 22, 2025 |
| K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation Dec 22, 2025 |
| K250756 — Pression Wave PRO External Counter-Pulsation System | Pression, Inc. Dec 22, 2025 |
| K252068 — MC2 Portable X-ray System | Oxos Medical Dec 22, 2025 |
| K243342 — KP Protective Face Mask | Kp Trading Co., Ltd. Dec 22, 2025 |
| K251605 — DIMPLO Implant System | DIMPLO, Ltd. Dec 22, 2025 |
| K251764 — Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science And Technology Co., Ltd. Dec 22, 2025 |
| K253903 — InnoClip Disposable Clip Applier | Taiwan Surgical Corporation Dec 22, 2025 |
| K252616 — Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. Dec 22, 2025 |
| K251159 — Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. Dec 22, 2025 |
| K252361 — AccurECG Analysis System (v2.0) | Accurkardia, Inc. Dec 22, 2025 |
| K253339 — Theracor | Stimlabs, LLC Dec 22, 2025 |
| K250959 — BioticsAI | Bioticsai, Inc. Dec 22, 2025 |
| K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Globus Medical, Inc. Dec 22, 2025 |
| K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs | Sorin Group Italia S.R.L. Dec 22, 2025 |
| K253222 — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. Dec 22, 2025 |
| K252856 — PeekMed web | Peek Health, S.A. Dec 22, 2025 |
| K252557 — Lumify Diagnostic Ultrasound System | Philips Ultrasound, LLC Dec 22, 2025 |
| K252981 — EmbraceMini | Empatica S.R.L. Dec 22, 2025 |
| K253769 — Instylla Delivery Kit | Instylla, Inc. Dec 22, 2025 |
| K253661 — TMINI Miniature Robotic System | THINK Surgical, Inc. Dec 22, 2025 |
| K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device | ETHICON, Inc. Dec 22, 2025 |
| K252673 — LacertaMatrix | Lacerta Life Science Dec 22, 2025 |
| K253781 — InnoClip Clip Applier | Taiwan Surgical Corporation Dec 22, 2025 |
| K252109 — RayStation (2024A SP3) | RaySearch Laboratories AB (PUBL) Dec 22, 2025 |
| K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service And Savings, Inc. Dec 19, 2025 |
| K251037 — Rectal Applicator | Nucletron B.V. Dec 19, 2025 |
| K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise | Siemens Healthcare GmbH Dec 19, 2025 |
| K252670 — Alzevita | TOPIA MEDTECH LIMITED Dec 19, 2025 |
| K251730 — LIA Console (542-7) | Leadoptik, Inc. Dec 19, 2025 |
| K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. Dec 19, 2025 |
| K232365 — Vivo 45 LS | Oconnell Regulatory Consultants, Inc. Dec 19, 2025 |
| K252480 — CE Deliver (DLV) | CapsoVision, Inc. Dec 19, 2025 |
| K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) | Guangdong Youmeng Electrical Technology Co., Ltd. Dec 19, 2025 |
| K250976 — Airbile-100 | Poskom Co., Ltd. Dec 19, 2025 |
| K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. Dec 19, 2025 |
| K253613 — Monkey Rings External Ring Fixation System | Paragon 28, Inc. Dec 19, 2025 |
| K253086 — LED Light Therapy Device (Models: SG-FM, SG-FE) | Sunglor Technology Co., Ltd. Dec 19, 2025 |
| K252892 — SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. Dec 19, 2025 |
| K252029 — AI-CVD | HeartLung Corporation Dec 19, 2025 |
| K253577 — IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) Dec 19, 2025 |
| K251050 — Pectus Versa System | Gm Dos Reis Industria E Comercio Dec 19, 2025 |
| K251751 — Spo2 Sensor CSS032D | Shenzhen Ykd Technology Co., Ltd. Dec 19, 2025 |
| K251074 — Tru Liver Health Test Panel | Truvian Health Dec 19, 2025 |
| K253202 — Hoffmann LRF System | Stryker GmbH Dec 19, 2025 |