| Saige-Dx (K253825) | DeepHealth, Inc. | 2026-06-15 |
| Electric Wheelchair (S500-6) (K260335) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 2026-06-15 |
| VERAFEYE Imaging and Guidance System (VF-VIS-002) (K260885) | Luma Vision Limited | 2026-06-15 |
| Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle (K253121) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2026-06-15 |
| Neodent Scannable Healing Abutment (K253922) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 |
| NeckTune™ 3D SA Cervical Cage (K260036) | Medyssey Co, Ltd. | 2026-06-15 |
| LungMaps (K253690) | Siemens Healthineers AG | 2026-06-15 |
| Permatage XT Settable Bone Putty (K261265) | Orthocon, Inc. | 2026-06-15 |
| MediAI-OA (K253172) | Crescom Co., Ltd. | 2026-06-15 |
| DRE Duo (K260482) | Jpi Healthcare Co, Ltd. | 2026-06-15 |
| Curajel™ Oral Gel (K260126) | USpharma, Ltd. | 2026-06-15 |
| Dynamo™ Spinal Cement; Salvo® Spine System (K260286) | Spine Wave, Inc. | 2026-06-15 |
| WatchMate Software (K260300) | Anumana, Inc. | 2026-06-15 |
| Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (K261604) | Neuroelectrics Barcelona S.L.U. | 2026-06-13 |
| Fast PCR Mini Respiratory Panel (K252932) | Autonomous Medical Devices Incorporated | 2026-06-12 |
| Disposable Blood Lancet (Soft) (K261634) | SteriLance Medical (Suzhou), Inc. | 2026-06-12 |
| ThinkQA 3 (K252937) | Dosisoft SA | 2026-06-12 |
| Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706) (K260346) | Polybell (Guangzhou) Limited | 2026-06-12 |
| Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) (K253196) | Midmark Corporation | 2026-06-12 |
| Exalta Proximal Tibia Plating System (K261207) | Tyber Medical, LLC | 2026-06-12 |
| Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System (K260102) | Stryker Corporation (Tornier, Inc.) | 2026-06-12 |
| cobas pulse blood glucose monitoring system (K252323) | Roche Diagnostics | 2026-06-12 |
| MEDRAD® Imaging Bulk Package Transfer Spike (K253688) | Bayer Medical Care, Inc. | 2026-06-12 |
| Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle (K260514) | CMT Health PTE., Ltd. | 2026-06-12 |
| Medical Monitor (40HT513D) (K261213) | Lg Electronics.Inc | 2026-06-12 |
| ADRx™ Admixture Device (K252987) | Epic Medical Pte. , Ltd. | 2026-06-12 |
| DYNE PORT (K252933) | Dyne Medical Group, Inc. | 2026-06-12 |
| OneStim-DUO Cardiac Stimulator (MP5003-4CO) (K253088) | Micropace Pty, Ltd. | 2026-06-12 |
| HARBOR Occlusion Device (K260635) | Nuvascular, Inc. | 2026-06-12 |
| Brainomix 360 Hyperdensity (K260406) | Brainomix Limited | 2026-06-12 |
| Barbed PDO Suture (K252171) | Sutura Medical Technology, Inc. | 2026-06-12 |
| Universal 1417PI (K252996) | Konica Minolta Healthcare Americas, Inc. | 2026-06-12 |
| Spiro-VISTA (K253437) | Spiro Robotics | 2026-06-12 |
| Cognitive Function Neuroimaging (cfNI) Software (1.0.0) (K253015) | VoxNeuro, Inc. | 2026-06-12 |
| Stelo Glucose Biosensor System (K260935) | Dexcom, Inc. | 2026-06-12 |
| BTL-899TT (K252963) | BTL Industries, Inc. | 2026-06-12 |
| WHILL (WHILL Model C2) (K261175) | Whill, Inc. | 2026-06-12 |
| Virtus (K261366) | Somnomed, Inc. | 2026-06-12 |
| Intense Pulsed Light Therapy Device (K261204) | Sanhe LEFIS Electronics Co., Ltd. | 2026-06-12 |
| UNEEG EpiSight System (K253607) | Uneeg Medical A/S | 2026-06-11 |
| Fluoride Varnish (Type A,Type C) (K253052) | Nagy Oral Technology Qinhuangdao Co., Ltd. | 2026-06-11 |
| 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) (K260710) | FloShield, Inc. | 2026-06-11 |
| Snorbliss® Anti-Snoring Device (K261251) | Endeavor Commerce, LLC | 2026-06-11 |
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| i-STAT hs-TnI cartridge with the i-STAT Alinity System (K253051) | Abbott Point of Care, Inc. | 2026-06-11 |
| ICON 35; ICON 45; ICON 60; ICON 30FAF (K260849) | Rehasense USA, Inc. | 2026-06-11 |
| Verge™ Microcatheter (K261610) | Instylla, Inc. | 2026-06-11 |
| Ion-L (K261209) | SurGenTec, LLC | 2026-06-11 |
| PROBEAT-CR (K260174) | Hitachi High-Tech Corp. | 2026-06-11 |
| Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145) | Smart Denture Conversions, LLC | 2026-06-11 |
| AViTA Breast Pump (K250129) | Avita Corporation | 2026-06-11 |
| Dental X-ray System (K250839) | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 |
| Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (K261256) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 |
| MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (K254087) | Synthes (USA) Products, LLC | 2026-06-11 |
| PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (K261292) | PR Personal Care Laboratories | 2026-06-11 |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K260322) | Mighty Oak Medical | 2026-06-11 |
| Anura Mobile Core SDK (M1) (K253650) | Nuralogix Corporation | 2026-06-11 |
| Rosetta SM, Rosetta SP (K260859) | Hass Corp. | 2026-06-11 |
| Dexter L6 System (K260653) | Distalmotion SA | 2026-06-11 |
| DeepXray Spina (K253192) | Alpha Intelligence Manifolds, Inc. | 2026-06-10 |
| LARS ACJ (K253115) | Movmedix S.A.S. | 2026-06-10 |
| Tinnitus Therapy (K260614) | Sivantos GmbH | 2026-06-10 |
| MSS - Humeral reverse liners extension (K261016) | Medacta International, SA | 2026-06-10 |
| Colli-Pee•Dx Urine Collection Kit (K254121) | DNA Genotek, Inc. | 2026-06-10 |
| 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) (K261329) | Centerline Biomedical | 2026-06-10 |
| Anteralign LS coverplate (K260810) | Tyber Medical, LLC | 2026-06-10 |
| “Tech-Image” Video Endoscope System (K260414) | Tech-Image CO., LTD. | 2026-06-10 |
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| Cryo And Thermo Therapy System (K253919) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2026-06-10 |
| Profoject™ Safety Pen Needles (K260855) | CMT Health PTE., Ltd. | 2026-06-10 |
| Penumbra System (Thunderbolt Aspiration Tubing) (K250690) | Penumbra, Inc. | 2026-06-10 |
| BOBBY Balloon Guide Catheter (K261549) | MicroVention, Inc., d/b/a Terumo Neuro | 2026-06-09 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K260802) | Materialise NV | 2026-06-09 |
| Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (K252914) | Hathor Professional Skincare , Ltd. | 2026-06-09 |
| Mother's Nature W1 Warming Wearable Breast Pump (K260864) | Shenzhen TPH Technology Co., Ltd. | 2026-06-09 |
| TekBrace Solo Soft Tissue Reinforcement Device (K261621) | Theramicro | 2026-06-09 |
| ChanPin Pedicle Screw Spinal System (K251251) | Chanpin Medtak Co., Ltd. | 2026-06-09 |
| LAP-iX2N (K253165) | Sejong Medical Co., Ltd. | 2026-06-09 |
| ERBECRYO 2 Cryosurgical Unit and Accessories (K261806) | Erbe Elektromedizin GmbH | 2026-06-09 |
| DESS Dental Smart Solutions (K260564) | Terrats Medical SL | 2026-06-09 |
| ES-Series (K260748) | E-Scopics | 2026-06-09 |
| EchoNext (K260332) | Pathwai, Inc. | 2026-06-08 |
| ELEOS™ with NanoCept® Technology Limb Salvage System (K253066) | Onkos Surgical, Inc. | 2026-06-08 |
| 2D Hip Planning Software (K261352) | One Ortho | 2026-06-08 |
| Lipocosm Harmonic System (K251944) | Lipocosm, LLC | 2026-06-08 |
| Apollo Quattro (APQ-10M) (K253542) | Weero Co., Ltd. | 2026-06-08 |
| Virgo Mobility Scooter (Virgo-D,Virgo-F) (K253257) | Jiangsu Intco Medical Products Co., Ltd. | 2026-06-08 |
| Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (K261402) | Dexcom, Inc. | 2026-06-08 |
| EyeBOX SNAP (K254086) | Oculogica, Inc. | 2026-06-05 |
| FieldFlex Steerable Sheath (K261492) | CenterPoint Systems, LLC | 2026-06-05 |
| VEOFIX Snap Off Screw (K253108) | Steps Ortho | 2026-06-05 |
| Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) (K253162) | Unimed Medical Supplies, Inc. | 2026-06-05 |
| Alma TED+ System (K251684) | Alma Lasers, Inc. | 2026-06-05 |
| Perfect-O Ostial Positioning Catheter (K260289) | Balosmark, Inc. | 2026-06-05 |
| Vial Adapter (K260301) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 |
| Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts (K260105) | Edwards Lifesciences | 2026-06-05 |
| Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test (K260754) | Assure Tech., LLC | 2026-06-05 |
| Power Wheelchair (N5515A, N5516, N5517A, N5519) (K260056) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2026-06-05 |
| APTUS Clavicle System 2.8 (K260761) | Medartis AG | 2026-06-05 |
| Catalyze (K253204) | BioTissue Holdings, Inc. | 2026-06-05 |