| K253274 — BedDot (G1) | Intelligent Dots, LLC Jun 25, 2026 |
| K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | GN Hearing A/S Jun 25, 2026 |
| K260992 — iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) | Neuralytix Jun 25, 2026 |
| K260790 — G-Series Grind Guard | ASESSO HEALTH, Inc. Jun 25, 2026 |
| K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC Jun 25, 2026 |
| K253560 — Enhanced Boundary for PCCT | Ge Medical Systems, LLC Jun 24, 2026 |
| K253263 — ConvaVAC Negative Pressure Wound Therapy System | Convatec Limited, Gdc Building Jun 24, 2026 |
| K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd Jun 24, 2026 |
| K260394 — Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) | Hangzhou Jimushi Meditech Co., Ltd. Jun 24, 2026 |
| K261866 — Concerto Versa Detachable Coil | Medtronic, Inc. Jun 24, 2026 |
| K260998 — Ceribell Neurology Review Software | Ceribell, Inc. Jun 24, 2026 |
| K261055 — AMSCO 700 Steam Sterilizer | STERIS Corporation Jun 24, 2026 |
| K252117 — Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. Jun 24, 2026 |
| K261023 — Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. Jun 24, 2026 |
| K261772 — Target Xtra Detachable Coil | Stryker Neurovscular Jun 24, 2026 |
| K261260 — HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation Jun 24, 2026 |
| K253404 — CLEAR Aspiration System | Insera Therapeutics, Inc. Jun 24, 2026 |
| K253393 — Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | Hangzhou AGS MedTech Co., Ltd. Jun 24, 2026 |
| K260669 — Endoform Dermal Template | Aroa Biosurgery , Ltd. Jun 24, 2026 |
| K251929 — SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. Jun 24, 2026 |
| K253199 — CURASYS 2 (EMDN0003) | CG Bio Co., Ltd. Jun 23, 2026 |
| K253211 — AQUABEAM Robotic System | Procept Biorobotics Jun 23, 2026 |
| K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation Jun 23, 2026 |
| K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) | Integra Lifesciences Production Corporation Jun 23, 2026 |
| K253176 — TearView | Beyond 700 Pty, Ltd. Jun 22, 2026 |
| K254287 — Medline Reusable Blood Pressure Cuff | Medline Industries, LP Jun 22, 2026 |
| K261075 — Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. Jun 22, 2026 |
| K260316 — CMN Capillary Function with Oncology Virtual Expert | Cercare Medical A/S Jun 22, 2026 |
| K261950 — Health Line Tearaway Introducer | Health Line International Corporation Jun 22, 2026 |
| K261279 — DeltaNEC Interbody System | Nexus Spine Jun 22, 2026 |
| K261342 — Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. Jun 22, 2026 |
| K253148 — RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express Jun 22, 2026 |
| K254011 — Flow Water-Based Personal Lubricant | LBDO Group, Inc. Jun 22, 2026 |
| K261076 — Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. Jun 22, 2026 |
| K253421 — Perfusion Measurement Platform v1 | Quantified Imaging Limited Jun 22, 2026 |
| K260369 — Dynamis Robotic Surgical System | LEM Surgical AG Jun 20, 2026 |
| K253776 — Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH Jun 18, 2026 |
| K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou And Science & Technology Development Corp. Jun 18, 2026 |
| K253058 — Portable DR Imaging System | Shantou Institute Of Ultrasonic Instruments Co., Ltd. Jun 18, 2026 |
| K253187 — SteriBest® Sterilization Tray System | Mastel Surgical Jun 18, 2026 |
| K253521 — ECMT-100 WMD | Ecm Therapeutics, Inc. Jun 18, 2026 |
| K261665 — CORUS Navigation System-GN | Providence Medical Technology, Inc. Jun 18, 2026 |
| K253131 — Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. Jun 18, 2026 |
| K254169 — SmartSpectra Vital Signs Monitor 1.0 | Presage Security, Inc. D/B/A Presage Technologies, Inc. Jun 18, 2026 |
| K253678 — MAMMOMAT B.brilliant (11372950) | Siemens Medical Solutions USA, Inc. Jun 18, 2026 |
| K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. Jun 18, 2026 |
| K260280 — NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid Egg | Hycor Biomedical Jun 18, 2026 |
| K261701 — Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. Jun 18, 2026 |
| K251232 — MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. Jun 18, 2026 |
| K260729 — Vascular Assist Occlusion Triage (VAOT) (v1.0) | GuideAI Health Jun 18, 2026 |