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 |
|---|---|---|---|
| Aug 21, 2026 | K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM Zeus Scientific | MOB |
| Aug 21, 2026 | K261354 | Electric wheelchair (D03) Foshan Sowell Medical Technology Co., Ltd., CN | ITI |
| Aug 21, 2026 | K261015 | Solo Scope Colonoscope System Gi View, Ltd., IL | FDF |
| Aug 21, 2026 | K260643 | Cimilre Dual Max Cimilre Co., Ltd., KR | HGX |
| Aug 21, 2026 | K260584 | BoneMRI Mriguidance B.V., NL | QIH |
| Aug 21, 2026 | K253817 | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La Immunodiagnostics Systems Limited, GB | LLL |
| Aug 21, 2026 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System Microport Orthopedics, Inc. | MBH |
| Aug 21, 2026 | K253726 | uAngio AVIVA CX Shanghai United Imaging Healthcare Co., Ltd., CN | OWB |
| Aug 21, 2026 | K253699 | Tempus ECG-PH Tempus AI, Inc. | SAT |
| Aug 21, 2026 | K253692 | AVVIGO+ Multi-Modality Guidance System Boston Scientific | DQK |
| Aug 21, 2026 | DEN250067 | ReneuRx (Neural Ice) Brixton Biosciences | SJA |
| Aug 21, 2026 | DEN250026 | Avulux Matap Ii, LLC | QEO |
| Aug 20, 2026 | K262515 | Kneu Platform (V2) Kneu Health Digital , Ltd., GB | GYD |
| Aug 20, 2026 | K262506 | Remex Spine Surgery Navigation - Universal Instruments Remex Medical Corp., TW | OLO |
| Aug 20, 2026 | K262113 | HardyDisk AST Tebipenem 10µg (TBP10) Hardy Diagnostics | JTN |
| Aug 20, 2026 | K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) Guangdong Youmeng Electrical Technology Co., Ltd., CN | HGX |
| Aug 20, 2026 | K261049 | SCALA® TL Spineart SA, CH | MAX |
| Aug 20, 2026 | K260817 | MIRA Surgical System Virtual Incision | SAB |
| Aug 20, 2026 | K260579 | Infinity® Acute Care System (IACS) VG8.1 Draeger Medical Systems, Inc. | MHX |
| Aug 20, 2026 | K260242 | CPETWise Platform Medibyt , Ltd., IL | BTY |
| Aug 20, 2026 | K253807 | Valence InVent Xtend (CVG-4101-VXA) Convergence Medical Sciences , Ltd., CA | MOD |
| Aug 20, 2026 | DEN250043 | Qoramatic Automated Stool Management Cm Technologies, Inc. | SJB |
| Aug 19, 2026 | K262622 | Swoop® Portable MR Imaging® System Hyperfine, Inc. | LNH |
| Aug 19, 2026 | K262537 | Versalock Sterile Plating System GM Dos Reis Industria e Comercio Ltda., BR | HRS |
| Aug 19, 2026 | K262070 | Diode Laser Therapy Systems (DL612A) Hebei Zollvan Medical Technology Co., Ltd., CN | GEX |
| Aug 19, 2026 | K261964 | ECHOLASER X4 Elesta S.P.A, IT | GEX |
| Aug 19, 2026 | K261686 | Elecsys Phospho-Tau (217P) Plasma Roche Diagnostics | SET |
| Aug 19, 2026 | K261413 | EXTRON 3;EXTRON 6 DRTECH Corporation, KR | OWB |
| Aug 19, 2026 | K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) CooperSurgical, Inc. | MQG |
| Aug 19, 2026 | K260799 | Nipro Dry Acid Concentrate Mixer Nipro Technical Solutions, Incoporated | KPO |
| Aug 19, 2026 | K260463 | ZEROS Dental Implant System Zeros Co., Ltd., KR | DZE |
| Aug 19, 2026 | K260209 | ENDOFLATOR+; Smart Smoke Evacuation Karl Storz SE & CO. KG, DE | HIF |
| Aug 19, 2026 | K254213 | Pascall Sensor Unit (PSU1) Pascall Systems, Inc. | OLT |
| Aug 19, 2026 | K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SH Shokz Health Global Limited, HK | LXB |
| Aug 19, 2026 | K253240 | PrecivityAD2 Test C2N Diagnostics, LLC | SET |
| Aug 19, 2026 | DEN250046 | Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) Vitestro, NL | SIW |
| Aug 18, 2026 | K262729 | TeKBrace Solo Soft Tissue Reinforcement Device Theramicro | QUW |
| Aug 18, 2026 | K262489 | BluEX Cervical Expandable Cage System L&K BIOMED Co., Ltd., KR | ODP |
| Aug 18, 2026 | K262479 | TearCare System Sight Sciences, Inc. | ORZ |
| Aug 18, 2026 | K262135 | Lancing device Tianjin Huahong Technology Co., Ltd., CN | QRL |
| Aug 18, 2026 | K261641 | Lower Limb AI (LLAI) AI Planning Logic, Inc. | QIH |
| Aug 18, 2026 | K260984 | HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) Axora Medical, Inc. | HIH |
| Aug 18, 2026 | K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHE Kossan International Sdn Bhd, MY | LZA |
| Aug 18, 2026 | K260266 | Tympendi (810) Grace Medical, Inc. | KHJ |
| Aug 18, 2026 | K254256 | LUOFUCON® Wound Matrix Huizhou Foryou Medical Devices Co., Ltd., CN | QSZ |
| Aug 18, 2026 | K254071 | p17 XR Microcatheter Wallaby Medical | QJP |
| Aug 17, 2026 | K261500 | KBA3D (v2.4.0) S.M.A.I.O, FR | LLZ |
| Aug 17, 2026 | K260224 | MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) ImpediMed Limited, AU | DSB |
| Aug 17, 2026 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Soluti KLS-Martin L.P. | JEY |
| Aug 17, 2026 | K254250 | MagicScan-1.5, GreenMR Serenity 1.5T Xingaoyi Medical Equipment Co.,Ltd, CN | LNH |