Latest 510(k) clearances
Newest first, 50 per page. Open a clearance to see any recalls that name it.
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2026 | K261448 | neXus Ultrasonic Surgical Aspirator System Misonix, LLC | LFL |
| Jul 30, 2026 | K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) Suite 201, National Innovation Centre, AU | OLO |
| Jul 30, 2026 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) Salter Labs | CCL |
| Jul 30, 2026 | K261288 | Handheld Ultrasound Scanner IMGFAX CO., LTD., CN | IYN |
| Jul 30, 2026 | K260980 | cmAngio® V2.0 Curemetrix, Inc. | QIH |
| Jul 30, 2026 | K260624 | Arthrex Radial Head Replacement System Arthrex, Inc. | KWI |
| Jul 30, 2026 | K260620 | SeptAlign (SPLN001) Spirair, Inc. | NHB |
| Jul 30, 2026 | K260566 | SMARTVERTIGO Vestibular Assessment System VertigoDx, Inc. | GWN |
| Jul 30, 2026 | K260161 | SmartGuide Disposable Guides and Grids UC-CARE , Ltd., IL | ITX |
| Jul 30, 2026 | K254038 | Motivista (CT-155) Click Therapeutics, Inc. | SAP |
| Jul 30, 2026 | K252042 | Sync AV II Temporary Pacing Catheter Swift Sync, Inc. | LDF |
| Jul 30, 2026 | K251959 | TnR Cranial Implant T&R BIOFAB CO., Ltd., KR | GXP |
| Jul 29, 2026 | K262240 | SSPC NXT Delivery Catheter CenterPoint Systems, LLC | DQY |
| Jul 29, 2026 | K262200 | Stone Clear (BWSC-LP9-02) Sonomotion, Inc. | QNA |
| Jul 29, 2026 | K261829 | Profoject Dual-Safety Pen Needles CMT Health PTE., Ltd., SG | FMI |
| Jul 29, 2026 | K261770 | Suture Button Repair System Skeletal Dynamics, Inc. | MBI |
| Jul 29, 2026 | K261766 | CPS Locator 3D Plus Delivery Catheter CenterPoint Systems, LLC | DQY |
| Jul 29, 2026 | K261210 | Cleerly Plaque Cleerly, Inc. | QIH |
| Jul 29, 2026 | K261205 | SPINEART Navigation Instrument System Spineart SA, CH | OLO |
| Jul 29, 2026 | K261058 | CraniUS Plate CraniUS, LLC | GWO |
| Jul 29, 2026 | K260588 | Cleerly LABS Cleerly, Inc. | LLZ |
| Jul 29, 2026 | K253526 | NAMIC Dilator and Sheath Medline Industries, LP | DYB |
| Jul 29, 2026 | K251908 | Emanate Tray Emanate Biomedical | OLR |
| Jul 28, 2026 | K261511 | Xpert Ankle Newclip Technics, FR | HRS |
| Jul 28, 2026 | K261430 | TruLift Expandable System Life Spine, Inc. | MAX |
| Jul 28, 2026 | K261427 | uMI Panvivo (uMI Panvivo M) Shanghai United Imaging Healthcare Co., Ltd., CN | KPS |
| 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/H Samsung Medison Co., Ltd., KR | IYN |
| Jul 28, 2026 | K261399 | ELISIO-HX Nipro Medical Corporation | QAX |
| Jul 28, 2026 | K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgica Hartalega NGC Sdn. Bhd., MY | KGO |
| Jul 28, 2026 | K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) Datex-Ohmeda, Inc. | FMZ |
| Jul 28, 2026 | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) See-Mode Technologies Pty, Ltd., AU | QDQ |
| Jul 28, 2026 | K253651 | Revi System Bluewind Medical , Ltd., IL | QXM |
| Jul 28, 2026 | K253450 | BodyTom Elite (NL4000) NeuroLogica Corp., a Samsung Company | JAK |
| Jul 28, 2026 | DEN250042 | CaRi-Heart Caristo Diagnostics , Ltd. | SIU |
| Jul 27, 2026 | K262474 | ND Needle Guidance System Accurate Access, LLC | ITX |
| Jul 27, 2026 | K262201 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter Shockwave Medical, Inc. | PPN |
| Jul 27, 2026 | K261759 | Euphora Rapid Exchange (RX) Balloon Dilatation Catheter Medtronic Ireland, IE | LOX |
| Jul 27, 2026 | K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set Merit Medical Systems, Inc. | DRE |
| Jul 27, 2026 | K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System Philips Ultrasound, LLC | IYN |
| Jul 27, 2026 | K261105 | Powered Aventus Thrombectomy System Inquis Medical | QEZ |
| Jul 27, 2026 | K260835 | ARCHIMEDES Biodegradable Stent (Medium) Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | FGE |
| Jul 27, 2026 | K260529 | Air Compression Massager (HY-1165) Xiamen High Top Electronic Technology Co., Ltd., CN | IRP |
| Jul 27, 2026 | K250419 | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand ( Plus EV Holdings, Inc. D/B/A Intimate Rose | OSD |
| Jul 26, 2026 | K261367 | Corsano CardioWatch 287-2 System Corsano Health B.V., NL | MSX |
| Jul 26, 2026 | K253576 | CorVista System® with PCWP Add-On Analytics For Life, Inc. | DQK |
| Jul 25, 2026 | K260382 | MONARCH Platform (MON-000008) Auris Health, Inc. | EOQ |
| Jul 25, 2026 | K253206 | METICULY Patient-specific CMF solution Meticuly Co., Ltd., TH | JEY |
| Jul 24, 2026 | K262462 | TheraSphere 360 Y-90 Management Platform Boston Scientific Corporation | LLZ |
| Jul 24, 2026 | K262383 | LumenCare Azure Nucletron B.V., NL | JAQ |
| Jul 24, 2026 | K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extre Philips Medical Systems Nederland B.V., NL | MOS |