| K251890 — Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. Feb 20, 2026 |
| K260205 — AS Software Version Asera | AS Software, LLC Feb 19, 2026 |
| K253002 — SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. Feb 19, 2026 |
| K260163 — AuST CSP Introducer | CenterPoint Systems, LLC Feb 19, 2026 |
| K260308 — TrueFit Bolus | Adaptiiv Medical Technologies, Inc. Feb 19, 2026 |
| K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) | Alphatec Spine, Inc. Feb 19, 2026 |
| K252733 — ATLAS Expandable Osteotomy Wedge System | MiRus, LLC Feb 19, 2026 |
| K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | Stryker Leibinger GmbH & Co KG Feb 19, 2026 |
| K253687 — Access anti-HBc Total | Beckman Coulter, Inc. Feb 19, 2026 |
| K254018 — Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. Feb 19, 2026 |
| K254188 — Meniscus Versaflex | GM Dos Reis Industria E Comercio Ltda. Feb 19, 2026 |
| K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) | Efofex, Inc. Feb 19, 2026 |
| K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System | Acclarent, Inc. Feb 19, 2026 |
| K254148 — VERTICALE GPS Instruments | Silony Medical GmbH Feb 19, 2026 |
| K260218 — LacertaMatrix | Lacerta Life Sciences Feb 19, 2026 |
| K251903 — Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation Feb 19, 2026 |
| K253203 — Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. Feb 19, 2026 |
| K252814 — Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe | CMT Health PTE., Ltd. Feb 19, 2026 |
| K252002 — Monaco RTP System (6.3) | Elekta Solutions AB Feb 19, 2026 |
| K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics Feb 18, 2026 |
| K252197 — Nobel Biocare S Series Implants | Nobel Biocare AB Feb 18, 2026 |
| K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | Stryker Endoscopy Feb 18, 2026 |
| K253643 — Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. Feb 18, 2026 |
| K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. Feb 18, 2026 |
| K252561 — BTL-754FF | BTL Industries, Inc. Feb 18, 2026 |
| K253539 — Alere NT-proBNP for Alinity i | Axis-Shield Diagnostics, Ltd. Feb 18, 2026 |
| K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. Feb 17, 2026 |
| K253599 — Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd Feb 17, 2026 |
| K260149 — Versus Catheter (VS110-9NB) | Liquet Medical, Inc. Feb 17, 2026 |
| K253524 — Adaptos®Fuse Bone Graft | Biomendex OY Feb 17, 2026 |
| K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Feb 17, 2026 |
| K251680 — Biosteon® Screw | Biocomposites, Ltd. Feb 17, 2026 |
| K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit | Fujifilm Corporation Feb 17, 2026 |
| K260130 — Willow 18 Guidewire | Arbor Endovascular, LLC Feb 13, 2026 |
| K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. Feb 13, 2026 |
| K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | VPIX Medical, Inc. Feb 13, 2026 |
| K252512 — Armada 14 NC PTA Catheter | ABBOTT MEDICAL Feb 13, 2026 |
| K243854 — Contour Light (CL-100) | Contour Research, LLC Feb 13, 2026 |
| K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. Feb 13, 2026 |
| K254105 — Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC Feb 13, 2026 |
| K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal | Alcon Laboratories, Inc. Feb 13, 2026 |
| K251742 — VELO Respiratory Test | Lex Diagnostics Limited Feb 13, 2026 |
| K252420 — Wearable Breast Pump (Model W12) | Shenzhen TPH Technology Co., Ltd. Feb 13, 2026 |
| K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. Feb 13, 2026 |
| K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. Feb 13, 2026 |
| K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. Feb 13, 2026 |
| K252400 — Endomina EZFuse system | Endo Tools Therapeutics S.A. Feb 13, 2026 |
| K253149 — Motion InBra (YM-8801) wearable breast pump | Medela, LLC Feb 13, 2026 |
| K251802 — STAR RF Ablation System | Merit Medical Systems, Inc. Feb 13, 2026 |
| K250233 — PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) Feb 13, 2026 |