| K250839 — Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. Jun 11, 2026 |
| K253052 — Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. Jun 11, 2026 |
| K261610 — Verge Microcatheter | Instylla, Inc. Jun 11, 2026 |
| K254145 — Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC Jun 11, 2026 |
| K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System | Synthes (USA) Products, LLC Jun 11, 2026 |
| K250129 — AViTA Breast Pump | Avita Corporation Jun 11, 2026 |
| K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. Jun 11, 2026 |
| K260710 — FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) | FloShield, Inc. Jun 11, 2026 |
| K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories Jun 11, 2026 |
| K261251 — Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC Jun 11, 2026 |
| K253650 — Anura Mobile Core SDK (M1) | Nuralogix Corporation Jun 11, 2026 |
| K260174 — PROBEAT-CR | Hitachi High-Tech Corp. Jun 11, 2026 |
| K253607 — UNEEG EpiSight System | Uneeg Medical A/S Jun 11, 2026 |
| K261209 — Ion-L | SurGenTec, LLC Jun 11, 2026 |
| K260322 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | Mighty Oak Medical Jun 11, 2026 |
| K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System | Abbott Point Of Care, Inc. Jun 11, 2026 |
| K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. Jun 11, 2026 |
| K251326 — Respiration Rate algorithm | Edwards Lifesciences, LLC Jun 11, 2026 |
| K260859 — Rosetta SM, Rosetta SP | Hass Corp. Jun 11, 2026 |
| K260653 — Dexter L6 System | Distalmotion SA Jun 11, 2026 |
| K260614 — Tinnitus Therapy | Sivantos GmbH Jun 10, 2026 |
| K260855 — Profoject Safety Pen Needles | CMT Health PTE., Ltd. Jun 10, 2026 |
| K253192 — DeepXray Spina | Alpha Intelligence Manifolds, Inc. Jun 10, 2026 |
| K253115 — LARS ACJ | Movmedix S.A.S. Jun 10, 2026 |
| K260414 — Tech-Image Video Endoscope System | Tech-Image CO., LTD. Jun 10, 2026 |
| K261016 — MSS - Humeral reverse liners extension | Medacta International, SA Jun 10, 2026 |
| K260810 — Anteralign LS coverplate | Tyber Medical, LLC Jun 10, 2026 |
| K254121 — Colli-PeeDx Urine Collection Kit | DNA Genotek, Inc. Jun 10, 2026 |
| K261329 — Intra-Operative Positioning System (IOPS) (MC-1);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 Jun 10, 2026 |
| K253919 — Cryo And Thermo Therapy System | Xiamen Weiyou Intelligent Technology Co., Ltd. Jun 10, 2026 |
| K261174 — RxSight® Insertion Device | Rxsight, Inc. Jun 10, 2026 |
| K250690 — Penumbra System (Thunderbolt Aspiration Tubing) | Penumbra, Inc. Jun 10, 2026 |
| K251251 — ChanPin Pedicle Screw Spinal System | Chanpin Medtak Co., Ltd. Jun 9, 2026 |
| K261549 — BOBBY Balloon Guide Catheter | MicroVention, Inc., D/B/A Terumo Neuro Jun 9, 2026 |
| K260564 — DESS Dental Smart Solutions | Terrats Medical SL Jun 9, 2026 |
| K253165 — LAP-iX2N | Sejong Medical Co., Ltd. Jun 9, 2026 |
| K261621 — TekBrace Solo Soft Tissue Reinforcement Device | Theramicro Jun 9, 2026 |
| K260864 — Mother's Nature W1 Warming Wearable Breast Pump | Shenzhen TPH Technology Co., Ltd. Jun 9, 2026 |
| K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) | Hathor Professional Skincare , Ltd. Jun 9, 2026 |
| K260748 — ES-Series | E-Scopics Jun 9, 2026 |
| K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories | Erbe Elektromedizin GmbH Jun 9, 2026 |
| K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner | Materialise NV Jun 9, 2026 |
| K253542 — Apollo Quattro (APQ-10M) | Weero Co., Ltd. Jun 8, 2026 |
| K253066 — ELEOS with NanoCept® Technology Limb Salvage System | Onkos Surgical, Inc. Jun 8, 2026 |
| K260332 — EchoNext | Pathwai, Inc. Jun 8, 2026 |
| K261402 — Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | Dexcom, Inc. Jun 8, 2026 |
| K251944 — Lipocosm Harmonic System | Lipocosm, LLC Jun 8, 2026 |
| K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. Jun 8, 2026 |
| K261352 — 2D Hip Planning Software | One Ortho Jun 8, 2026 |
| K260761 — APTUS Clavicle System 2.8 | Medartis AG Jun 5, 2026 |