| K261288 — Handheld Ultrasound Scanner | IMGFAX CO., LTD. Jul 30, 2026 |
| K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre Jul 30, 2026 |
| K251959 — TnR Cranial Implant | T&R BIOFAB CO., Ltd. Jul 30, 2026 |
| K261448 — neXus Ultrasonic Surgical Aspirator System | Misonix, LLC Jul 30, 2026 |
| K261835 — LOGIQ Focus | GE Medical Systems Ultrasound And Primary Care Diagnostics Jul 30, 2026 |
| K254038 — Motivista (CT-155) | Click Therapeutics, Inc. Jul 30, 2026 |
| K260588 — Cleerly LABS | Cleerly, Inc. Jul 29, 2026 |
| K251908 — Emanate Tray | Emanate Biomedical Jul 29, 2026 |
| K261205 — SPINEART Navigation Instrument System | Spineart SA Jul 29, 2026 |
| K262200 — Stone Clear (BWSC-LP9-02) | Sonomotion, Inc. Jul 29, 2026 |
| K261210 — Cleerly Plaque | Cleerly, Inc. Jul 29, 2026 |
| K262240 — SSPC NXT Delivery Catheter | CenterPoint Systems, LLC Jul 29, 2026 |
| K261770 — Suture Button Repair System | Skeletal Dynamics, Inc. Jul 29, 2026 |
| K253526 — NAMIC Dilator and Sheath | Medline Industries, LP Jul 29, 2026 |
| K261829 — Profoject Dual-Safety Pen Needles | CMT Health PTE., Ltd. Jul 29, 2026 |
| K261058 — CraniUS Plate | CraniUS, LLC Jul 29, 2026 |
| K261766 — CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC Jul 29, 2026 |
| K261399 — ELISIO-HX | Nipro Medical Corporation Jul 28, 2026 |
| K260303 — See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. Jul 28, 2026 |
| K253450 — BodyTom Elite (NL4000) | NeuroLogica Corp., A Samsung Company Jul 28, 2026 |
| K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. Jul 28, 2026 |
| K261427 — uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. Jul 28, 2026 |
| K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Hartalega NGC Sdn. Bhd. Jul 28, 2026 |
| K253651 — Revi System | Bluewind Medical , Ltd. Jul 28, 2026 |
| K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. Jul 28, 2026 |
| DEN250042 — CaRi-Heart | Caristo Diagnostics , Ltd. Jul 28, 2026 |
| K261511 — Xpert Ankle | Newclip Technics Jul 28, 2026 |
| K261430 — TruLift Expandable System | Life Spine, Inc. Jul 28, 2026 |
| K262474 — ND Needle Guidance System | Accurate Access, LLC Jul 27, 2026 |
| K261310 — FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. Jul 27, 2026 |
| K262201 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. Jul 27, 2026 |
| K261759 — Euphora Rapid Exchange (RX) Balloon Dilatation Catheter | Medtronic Ireland Jul 27, 2026 |
| K260835 — ARCHIMEDES Biodegradable Stent (Medium) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) Jul 27, 2026 |
| K261105 — Powered Aventus Thrombectomy System | Inquis Medical Jul 27, 2026 |
| K250419 — Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | Plus EV Holdings, Inc. D/B/A Intimate Rose Jul 27, 2026 |
| K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC Jul 27, 2026 |
| K260529 — Air Compression Massager (HY-1165) | Xiamen High Top Electronic Technology Co., Ltd. Jul 27, 2026 |
| K261367 — Corsano CardioWatch 287-2 System | Corsano Health B.V. Jul 26, 2026 |
| K253576 — CorVista System® with PCWP Add-On | Analytics For Life, Inc. Jul 26, 2026 |
| K260382 — MONARCH Platform (MON-000008) | Auris Health, Inc. Jul 25, 2026 |
| K253206 — METICULY Patient-specific CMF solution | Meticuly Co., Ltd. Jul 25, 2026 |
| K261274 — EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes | Cook Ireland, Ltd. Jul 24, 2026 |
| K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp Jul 24, 2026 |
| K261364 — Atellica CH Acetaminophen 2 (ACTM) | Siemens Healthcare Diagnostics, Inc. Jul 24, 2026 |
| K261488 — OBSIDIO Conformable Embolic | Boston Scientific Corporation Jul 24, 2026 |
| K260259 — DiscreetDuo Flow Wearable Breast Pump (Model S3) | Shenzhen TPH Technology Co., Ltd. Jul 24, 2026 |
| K262152 — VS-370CF, VS-370CT | VISION MEDICAL Co., Ltd. Jul 24, 2026 |
| K260948 — Air Compression Massager (EP30B001 I) | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. Jul 24, 2026 |
| K261267 — Careflux H60;Careflux H70;Careflux V500 | Fresenius Medical Care Renal Therapies Group, LLC Jul 24, 2026 |
| K253943 — Tiger 2 System | Zavation Medical Products, LLC Jul 24, 2026 |