| K261823 — da Vinci Surgical System, Model IS5000 | Intuitive Surgical, Inc. Sep 8, 2026 |
| K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) | Zhejiang Geyi Medical Instrument Co., Ltd. Sep 8, 2026 |
| K260229 — Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. Sep 8, 2026 |
| K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) | Shenzhen Osto Medical Technology Co.,Ltd Sep 6, 2026 |
| K260396 — KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | Fidelity BioPharma Co. Sep 6, 2026 |
| K261684 — FreezeSpray TA | Cryosurgery, Inc. Sep 5, 2026 |
| K254135 — LipoSurg ARTIST | NOUVAG AG Sep 5, 2026 |
| K262292 — Gastric Alimetry | Alimetry , Ltd. Sep 4, 2026 |
| K253836 — FCT iStream Phase 2 | Fujifilm Corporation Sep 4, 2026 |
| K262235 — ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) | Medtronic Xomed, Inc. Sep 4, 2026 |
| K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) | Sentinel Medical Technologies, Sep 4, 2026 |
| K261057 — ActivaScrew Cannulated COM | Bioretec, Ltd. Sep 4, 2026 |
| K260525 — NextMR Spine | MRI2CT, Inc. Sep 4, 2026 |
| K254264 — Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) Sep 4, 2026 |
| K262277 — 70 NeuGlide Catheter | Piraeus Medical, Inc. Sep 4, 2026 |
| K253909 — NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. Sep 4, 2026 |
| K260035 — Digital Indeflator INFLANTE | UAB Telemedicina Sep 4, 2026 |
| K262130 — ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. Sep 4, 2026 |
| K262060 — 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC Sep 4, 2026 |
| K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O Sep 4, 2026 |
| K260331 — IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | Siemens Healthcare Diagnostics Products, Ltd. Sep 4, 2026 |
| K261935 — Surgical and Prosthetic Trays | Dentsply Sirona, Inc. Sep 4, 2026 |
| K254262 — Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA | Ortho Clinical Diagnostics Inc. (QuidelOrtho) Sep 4, 2026 |
| K253529 — Peerbridge COR MDx (Cor MDx) | Peerbridge Health, Inc. Sep 4, 2026 |
| DEN250044 — STEMI AI ECG Model | Powerful Medical, Inc. Sep 3, 2026 |
| K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 | Filmecc Co., Ltd. Sep 3, 2026 |
| K262769 — Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) | Orthocon, Inc. Sep 3, 2026 |
| K262243 — Profisil Free | Kettenbach GmbH & Co. KG Sep 3, 2026 |
| K253989 — HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) | Maxigen Biotech, Inc. Sep 3, 2026 |
| K262460 — Rezum System | Boston Scientific Sep 3, 2026 |
| K254035 — Mayumi Thrombectomy System | MicroVention, Inc., D/B/A Terumo Neuro Sep 3, 2026 |
| K260503 — Triton 1 System | Neptune Medical, Inc. Sep 3, 2026 |
| K254000 — Happy Health Blood Pressure Monitor | Happy Health, Inc. Sep 3, 2026 |
| K262315 — NeuroBlate System | Monteris Medical Sep 3, 2026 |
| K251794 — Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. Sep 3, 2026 |
| K253673 — Mcare System (MW-20) | Marani Health, Inc. Sep 3, 2026 |
| K261647 — Tempo Plating System; Ultra Compression Screw System | Pace Surgical Sep 3, 2026 |
| K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) | Philips Consumer Lifestyle B.V. Sep 3, 2026 |
| K261800 — Helo Max Thrombectomy System (HEL2090) | Endovascular Engineering Sep 3, 2026 |
| K253948 — Momentum Acetabular Cup System | United Orthopedic Corporation Sep 2, 2026 |
| K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound And Primary Care Diagnostics Sep 2, 2026 |
| K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) | Zhengzhou PZ Laser Slim Technology Co., Ltd. Sep 2, 2026 |
| K262364 — Ellian Enigma RF Device | Ellian Corp Sep 2, 2026 |
| K262153 — Pivot Insulin Delivery System | Modular Medical, Inc. Sep 2, 2026 |
| K253065 — Aevumed SUPERCYNCH Button System | Aevumed, Inc. Sep 2, 2026 |
| K262809 — ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC Sep 2, 2026 |
| K261311 — HYALOMATRIX | Anika Therapeutics, Inc. Sep 2, 2026 |
| K254090 — I-View® | Hologic, Inc. Sep 2, 2026 |
| K254026 — 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) | Flexicare Medical Limited. Sep 2, 2026 |
| K261749 — Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth Sep 2, 2026 |