| K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System | Spineart SA May 1, 2026 |
| K253663 — Zeta Navigation System | Zeta Surgical, Inc. May 1, 2026 |
| K260314 — Ancora-SB | Aspero Medical, Inc. May 1, 2026 |
| K252073 — VOCO Profluorid Varnish + BioMin | Voco GmbH May 1, 2026 |
| K260910 — EndoTool IV Cloud 1.0 | Glooko, Inc. May 1, 2026 |
| K250680 — Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. Apr 30, 2026 |
| K253436 — c-med0 alpha | Cosinuss GmbH Apr 30, 2026 |
| K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. Apr 30, 2026 |
| K253064 — Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) | Xiamen Weiyou Intelligent Technology Co., Ltd. Apr 30, 2026 |
| K254189 — Synapse 3D Base Tools (V7.2) | Fujifilm Corporation Apr 30, 2026 |
| DEN250023 — Aurie System | Cathbuddy, Inc. Apr 30, 2026 |
| K253976 — iLet ACE Pump | Beta Bionics, Inc. Apr 30, 2026 |
| K252455 — FSYX Ocular Pressure Adjusting Pump | Balance Ophthalmics, Inc. Apr 30, 2026 |
| K261067 — BEE PLIF Cage | NGMedical GmbH Apr 30, 2026 |
| K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. Apr 30, 2026 |
| K251583 — Ambu® Virobac II® Exhalation Filter | Ambu A/S Apr 30, 2026 |
| K252858 — 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) | Kms Medical Technology Co., Ltd. Apr 30, 2026 |
| K261404 — UltraEZ | Ultradent Products, Inc. Apr 30, 2026 |
| K252503 — Intelligent NR | Canon, Inc. Apr 30, 2026 |
| K252849 — AffloVest® Mobile Airway Clearance Therapy | Tactile Medical Apr 30, 2026 |
| K260342 — AllTest Strep A Rapid Test | Hangzhou AllTest Biotech Co., Ltd. Apr 30, 2026 |
| K260589 — ES-Series | E-Scopics Apr 29, 2026 |
| K254184 — syngo Application Software | Siemens Medical Solutions USA, Inc. Apr 29, 2026 |
| K261086 — Break Wave | Sonomotion, Inc. Apr 29, 2026 |
| K261094 — YellowStar | Asclepion Laser Technologies GmbH Apr 29, 2026 |
| K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES | GEO MEDICAL CO., LTD. Apr 29, 2026 |
| K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. Apr 29, 2026 |
| K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) | Shenzhen Root Innovation Technology Co., Ltd. Apr 29, 2026 |
| K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. Apr 29, 2026 |
| K252542 — LEO Spinal System | ZheJiang Decans Medical Devices Co., Ltd. Apr 29, 2026 |
| K260606 — Echo Large Bore Introducer Sheath | Echo Medical, LLC Apr 29, 2026 |
| K253401 — SCRIPT Implant System | Globus Medical, Inc. Apr 29, 2026 |
| K252471 — Paptizer 360 | LiViliti Health Products Corporation Apr 29, 2026 |
| K253682 — DeepHealth ProstateAI | Quantib B.V. Apr 29, 2026 |
| K252464 — Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. Apr 28, 2026 |
| K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | Guangzhou Wondfo Biotech Co., Ltd. Apr 28, 2026 |
| K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. Apr 28, 2026 |
| K253940 — M.U.S.T. Pedicle Screw System - Extension | Medacta International S.A. Apr 28, 2026 |
| K260248 — Ultra-Fast Warm | Kitazato Corporation Apr 28, 2026 |
| K253243 — Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC Apr 28, 2026 |
| K260194 — Vacuum Pump (Model: AD-VPUM-500) | Sheng Sheng Yi (Beijing) Technology Company Limited Apr 28, 2026 |
| K260121 — Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. Apr 28, 2026 |
| K252424 — Anti-HCV Next | Abbott Laboratories Apr 28, 2026 |
| K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) | Dolanvy (Suzhou) Medical Technology Co., Ltd. Apr 28, 2026 |
| K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. Apr 28, 2026 |
| K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC Apr 28, 2026 |
| K252409 — TearCare MGX System | Sight Sciences, Inc. Apr 27, 2026 |
| K260660 — SABER-C System | Elevation Spine Apr 27, 2026 |
| K252445 — Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC Apr 27, 2026 |
| K261032 — NovoKnee (SteriKnee) | NovoSource Apr 27, 2026 |