| 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 |
| K250998 — CO2 Laser Therapy System (Model: LFS-D9U) | Sanhe Lefis Electronics Co., Ltd. Dec 19, 2025 |
| K252754 — Wearable Electric Breast Pump (YM-8803) | Guangdong Youmeng Electrical Technology Co., Ltd. Dec 19, 2025 |
| K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) | Ningbo Ranor Medical Science & Technology Co., Ltd. Dec 19, 2025 |
| K252284 — eMurmur Heart AI | Csd Labs Dec 19, 2025 |
| K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. Dec 19, 2025 |
| K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. Dec 19, 2025 |
| K251572 — eRapid with eTrack System | Pari Respiratory Equipment, Inc. Dec 19, 2025 |
| K253161 — Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. Dec 19, 2025 |
| K251152 — DBLG2 | Diabeloop Dec 19, 2025 |
| K251077 — JOULE 1064nm System and Accessories | Sciton, Inc Dec 19, 2025 |
| K254063 — iCEM Universal Plus | Kulzer, LLC Dec 19, 2025 |
| K253733 — STAR Apollo Mapping System | Rhythm AI, Ltd. Dec 19, 2025 |
| K251469 — Endura Ureteral Stent and Stent Set | Cathegenix (Xiamen) Co., Ltd. Dec 19, 2025 |
| K252877 — SANDRO Dual | Wontech Co., Ltd. Dec 19, 2025 |
| K252974 — EMPOWR Knee | Encore Medical L.P. Dec 19, 2025 |
| K252781 — MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. Dec 19, 2025 |
| K253054 — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. Dec 19, 2025 |
| K251402 — LIA-1 Catheter (542-1) | Leadoptik, Inc. Dec 19, 2025 |
| K252780 — LCD Monitor (CL1902A, CL2103F) | Shenzhen Beacon Display Technology Co., Ltd. Dec 19, 2025 |
| K250864 — MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG Dec 19, 2025 |
| K253373 — Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. Dec 19, 2025 |
| K252863 — ClearCalc Model RADCA V2.6 | Radformation, Inc. Dec 19, 2025 |