| K250476 — NizPlant Dental Implant System | Paragon Implant Mfg., LLC Dec 23, 2025 |
| K253312 — OrangeCAD Med Abutments | Orangecad Med GmbH Dec 23, 2025 |
| K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) | Dongguan Yijiaming Technology Co., Ltd. Dec 23, 2025 |
| K253675 — OsteoRemedies Hip Spacer System | Osteoremedies, LLC Dec 23, 2025 |
| K254163 — VarioSurg 4 | Nakanishi, Inc. Dec 23, 2025 |
| K252379 — AIR Recon DL | Ge Medical Systems, LLC Dec 23, 2025 |
| K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | Hong Qiangxing (Shenzhen) Electronics Limited Dec 23, 2025 |
| K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) | Linhejiacheng (Shenzhen) E-Commerce Co., Ltd. Dec 23, 2025 |
| K251978 — LIAISON NES FLU A/B, RSV & COVID-19 | Diasorin Molecular, LLC Dec 23, 2025 |
| K253239 — Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. Dec 23, 2025 |
| K253341 — Custom Abutments AS | Medentika GmbH Dec 23, 2025 |
| DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | DiaSorin, Inc. Dec 23, 2025 |
| K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) | Bruno Vision Care, LLC Dec 23, 2025 |
| K252835 — Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. Dec 23, 2025 |
| K253122 — Sim&Size | Sim&Cure Dec 23, 2025 |
| K252187 — Aura Glide (FC40) | Aura Medical, LLC Dec 23, 2025 |
| K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. Dec 23, 2025 |
| K253091 — ART-Plan+ (v3.1.0) | Therapanacea Sas Dec 23, 2025 |
| K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card | Healgen Scientific,, LLC Dec 23, 2025 |
| K253754 — Philips Lumea IPL | Philips Consumer Lifestyle B.V. Dec 23, 2025 |
| K253281 — UpDoc | Updoc, Inc. Dec 23, 2025 |
| K251800 — Healgen® URS Test Strips | Healgen Scientific,, LLC Dec 23, 2025 |
| K252633 — UNITY DX (UDX) | Cylite Pty. , Ltd. Dec 23, 2025 |
| K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) | Hycor Biomedical Dec 23, 2025 |
| DEN250004 — QIKCAP System | Hai Solutions Dec 23, 2025 |
| K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) | Edan Instruments, Inc. Dec 23, 2025 |
| K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) Dec 23, 2025 |
| K251958 — VEINOPLUS Back | Dynapulse Medical Dec 23, 2025 |
| 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 |