| K260048 — Elecsys Anti-HAV IgM | Roche Diagnostics Apr 7, 2026 |
| K260942 — AuST Steerable Sheath | CenterPoint Systems, LLC Apr 7, 2026 |
| K260049 — Elecsys Anti-HBc IgM | Roche Diagnostics Apr 7, 2026 |
| K253952 — Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. Apr 7, 2026 |
| K253801 — ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. Apr 7, 2026 |
| K253905 — PrimeSight UltraView System | Cogentix Medical, Inc. Apr 7, 2026 |
| K254191 — IWD-Gel | InnovaCorium, Inc. Apr 7, 2026 |
| K260466 — Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang Shuyou Surgical Instrument Co., Ltd. Apr 7, 2026 |
| K260046 — Elecsys Anti-HBc II | Roche Diagnostics Apr 7, 2026 |
| K252116 — Firefighter Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. Apr 7, 2026 |
| K253946 — Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) | Shenzhen Root Innovation Technology Co., Ltd. Apr 7, 2026 |
| K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies Apr 6, 2026 |
| K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. Apr 6, 2026 |
| K252809 — in2 Smart (in2S) | Virility Medical , Ltd. Apr 6, 2026 |
| K252182 — SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Apr 6, 2026 |
| K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. Apr 6, 2026 |
| K253862 — APERTO Lucent MRI System | Fujifilm Corporation Apr 6, 2026 |
| K250208 — SPECTRA Wearable 2 | Uzinmedicare Co., Ltd. Apr 6, 2026 |
| K254091 — GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. Apr 6, 2026 |
| K260459 — VANES Delivery System (VDS) | Zoll Respicardia, Inc. Apr 6, 2026 |
| K253025 — Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC Apr 6, 2026 |
| K254084 — AETOS Shoulder System - CONCELOC Glenoids | Smith & Nephew, Inc. Apr 6, 2026 |
| K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | Esaote, S.P.A. Apr 6, 2026 |
| K253036 — Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. Apr 6, 2026 |
| K260724 — MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. Apr 3, 2026 |
| K260524 — uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. Apr 3, 2026 |
| K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH Apr 3, 2026 |
| K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH Apr 3, 2026 |
| K260363 — Ceribell Brain Monitor Headband | Ceribell, Inc. Apr 3, 2026 |
| DEN240071 — neuropacs | Automated Imaging Diagnostics, LLC Apr 3, 2026 |
| K254153 — Single-use Video Scope; PB Digital Controller | Mirco-Tech (Nanjing) Co., Ltd. Apr 3, 2026 |
| K254066 — Etiometry Platform | Etiometry, Inc. Apr 3, 2026 |
| K250074 — HYALEX® MTP Hemiarthroplasty Implant | Hyalex Orthopaedics, Inc. Apr 3, 2026 |
| K253340 — Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. Apr 3, 2026 |
| K253042 — Tyber Medical Trauma Screw | Tyber Medical, LLC Apr 3, 2026 |
| K252495 — LSSA (NP-200) | Newpong Co., Ltd. Apr 3, 2026 |
| K254060 — Life Saving Tourniquet | TW Medical Apr 3, 2026 |
| K253674 — Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) Apr 3, 2026 |
| K252386 — Hot and Cold Compression System (A02-C-032) | Chengdu Cryo-Push Medical Technology Co.,Ltd Apr 3, 2026 |
| K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Apr 3, 2026 |
| K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) | Cixi Ruihong Electric Appliance Co., Ltd. Apr 3, 2026 |
| K260719 — mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH Apr 3, 2026 |
| K253056 — Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. Apr 3, 2026 |
| K253962 — ClearCheck (RADCC V2.7) | Radformation, Inc. Apr 3, 2026 |
| K260184 — Onclarity Self-Collection Kit | Becton, Dickinson And Company Apr 2, 2026 |
| K250516 — SMART M-CELL PRP Concentration System | Miracell Co., Ltd. Apr 2, 2026 |
| K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics Apr 2, 2026 |
| K252246 — Leforte MMF System | Jeil Medical Corporation Apr 2, 2026 |
| K252709 — Wireless Probe Type Ultrasound Scanner | Xuzhou Yongkang Electronic Science Technology Co., Ltd. Apr 2, 2026 |
| K254022 — FLASH Flex Aorto-Ostial Angioplasty System | Verge Medical, Inc. Apr 2, 2026 |