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 |
|---|---|---|---|
| Oct 14, 2026 | K262432 | CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test CorDx, Inc. | SCA |
| Oct 14, 2026 | K262044 | Mediclose Cartridge System Health Value Creation B.V. (trading as Corporis Medical), NL | OCW |
| Oct 14, 2026 | K262042 | Sterilization Cassette (CASS-1) Alliedstar Medical Equipment Co., Ltd., CN | KCT |
| Oct 14, 2026 | K261961 | Ntegrate Threaded Nail System Nvision Biomedical Technologies | HWC |
| Oct 14, 2026 | K261169 | Power Wheelchair (D39) Anhui JBH Medical Apparatus Co., Ltd., CN | ITI |
| Oct 14, 2026 | K260676 | Radius VSM and Accessories Masimo Corporation | MHX |
| Oct 14, 2026 | K260581 | KARL STORZ Flexible Video Neuro-Endoscope Karl Storz SE & CO. KG, DE | GWG |
| Oct 14, 2026 | K260264 | Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) Shanghai Medi Astro Technology Co., Ltd., CN | ETA |
| Oct 13, 2026 | K263257 | Electrically Powered Wheelchair (YC-01) Yurob Rehabilitation Medical Co., Ltd., CN | ITI |
| Oct 13, 2026 | K262652 | Electric Wheelchair (CN501) Zhejiang Shimo Technology Co., Ltd., CN | ITI |
| Oct 13, 2026 | K262433 | OrthoFit Aligner (OrthoFit Aligner A2) Spident Co., Ltd., KR | DYH |
| Oct 13, 2026 | K261572 | Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) Keyue (Hangzhou) Medical Information Technology Co., Ltd., CN | GEX |
| Oct 13, 2026 | K261321 | Yomi S Robotic System Neocis, Inc. | QRY |
| Oct 13, 2026 | K252288 | TECAR Therapy Device (TC2000, TC2001) Shenzhen Dongdixin Technology Co., Ltd., CN | PBX |
| Oct 11, 2026 | K253717 | Helo Return Endovascular Engineering, Inc. | SHJ |
| Oct 9, 2026 | K263154 | CarboClear® Cervical Navigated Instruments CarboFix Orhtopedics , Ltd., IL | OLO |
| Oct 9, 2026 | K262902 | ECHELON Synergy Fujifilm Corporation, JP | LNH |
| Oct 9, 2026 | K262834 | Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5 Shenzhen Jianchao Intelligent Technology Co., Ltd., CN | OAP |
| Oct 9, 2026 | K262352 | IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) Shenzhen Jianchao Intelligent Technology Co., Ltd., CN | OHT |
| Oct 9, 2026 | K262301 | Rapid ICH (v4.0) Ischemaview, Inc. | QAS |
| Oct 9, 2026 | K262090 | Fertilis microICSI Device Fertilis Pty, Ltd., AU | MQK |
| Oct 9, 2026 | K262068 | Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) CathRx, Ltd., AU | DRF |
| Oct 9, 2026 | K261649 | Excelsior Reach Microcatheter Stryker Neurovascular | QJP |
| Oct 9, 2026 | K261521 | Sleep Analysis Module Neurotronics, LLC | OLZ |
| Oct 9, 2026 | K261234 | The D-Tip Denudation Pipette Allwin Medical Devices, Inc. | MQH |
| Oct 9, 2026 | K260913 | CMF Titanium Splints Materialise NV, BE | DZJ |
| Oct 9, 2026 | K260687 | VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual Monitoring Syste Vivachek Biotech (Hangzhou) Co., Ltd., CN | NBW |
| Oct 9, 2026 | K260156 | TruVision Single-Use 1.9mm Arthroscopy System Nexus CMF, LLC | HRX |
| Oct 9, 2026 | K260096 | Wishbone HAE Wishbone SA, BE | NPM |
| Oct 9, 2026 | K260080 | Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler Medical Components, Inc. | LJS |
| Oct 8, 2026 | K263680 | One Coat Bond; One Coat Bond SL Dent4You AG, CH | KLE |
| Oct 8, 2026 | K263150 | V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic U Samsung Medison Co., Ltd., KR | IYN |
| Oct 8, 2026 | K262346 | CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode L Wuhan Phomed Technology Co., Ltd., CN | GEX |
| Oct 8, 2026 | K262244 | Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade Stryker Instruments | LFL |
| Oct 8, 2026 | K261805 | NEXT-Cue Neuroxt, Inc., KR | QWT |
| Oct 8, 2026 | K261617 | Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (R Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Oct 8, 2026 | K260426 | MeCare Alpha (MCA2019) IVT Medical, Ltd., IL | OMP |
| Oct 7, 2026 | K263159 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments Centinel Spine, LLC | QLQ |
| Oct 7, 2026 | K262822 | Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) Zhongshan GL Electronics Co. , Ltd., CN | BTA |
| Oct 7, 2026 | K262378 | Dr.AlignNavi InnoDtech, Inc., KR | PNN |
| Oct 7, 2026 | K262368 | B. anthracis Real-time PCR Assay Centers for Disease Control and Prevention | NHT |
| Oct 7, 2026 | K262134 | NeuroDR Deep Reasoning Ai, Inc. | QIH |
| Oct 7, 2026 | K261733 | Ligence Heart UAB Ligence, LT | QIH |
| Oct 7, 2026 | K261692 | Diode Laser Hair Removal Machine (QDTM-03) Beijing Nubway S&T Co., Ltd., CN | GEX |
| Oct 7, 2026 | K261120 | APEX 3D S Diamond Tibia Paragon 28, Inc. | HSN |
| Oct 7, 2026 | K260092 | Vista AI Scan Vista AI, Inc. | LNH |
| Oct 7, 2026 | K260075 | eClinics Ceiba Healthcare US, Inc. | MSX |
| Oct 6, 2026 | K262798 | LOBO Vascular Occlusion System Okami Medical, Inc. | KRD |
| Oct 6, 2026 | K262516 | TSK OptiXion Tsk Laboratory, Japan, JP | QYM |
| Oct 6, 2026 | K262043 | MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging B Bayer Medical Care, Inc. | DXT |