Recent FDA 510(k) clearances
414 recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Karl Storz SE & CO. KG with 5. Data last updated 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from U.S. FDA openFDA
Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
414 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Karl Storz SE & CO. KG (5). Each record links to a full report and the official source.
Last updated 2026-11-03. Source: U.S. FDA openFDA.
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- Karl Storz SE & CO. KG (5)
- Roche Diagnostics (4)
- Anhui JBH Medical Apparatus Co., Ltd. (4)
- Zhenjiang Assure Medical Equipment Co., Ltd. (4)
- Beckman Coulter, Inc. (3)
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What are the top recent FDA 510(k) clearances right now?
Browse 35 more matching record reports
- Endox High Level Disinfectant (K254094): 510(k) cleared for Whiteley USA, Inc.
- BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company
- Carecube Negative Pressure Isolation Chamber (1BY) (K260180): 510(k) cleared for Carecubes, Inc.
- AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
- Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
- Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.
- TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.
- Helo Return (K253717): 510(k) cleared for Endovascular Engineering, Inc.
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Wishbone HAE (K260096): 510(k) cleared for Wishbone SA
- Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.
- eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.
- Vista AI Scan (K260092): 510(k) cleared for Vista AI, Inc.
- MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
- Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.
- Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.
- Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
- OAB Delivery Catheter (K253422): 510(k) cleared for Cognition Medical Corp.
- cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.
- Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
- Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics
- Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co.
- VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.
- Firstar Dental Electric Motor (K260027): 510(k) cleared for FDC Technology Industry Co.
- ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
- QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) (K260250): 510(k) cleared for QT Medical, Inc.
- THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210): 510(k) cleared for Hyundai Bioland Co., Ltd.
- DistaSense(TM) (v1) (K254058): 510(k) cleared for Life Detection Technologies
- easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291): 510(k) cleared for Ezisurg Medical Co., Ltd.
- TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.
- Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.
- CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.
- UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG
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Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)
Frequently asked questions
How many recent FDA 510(k) clearances are listed?
414 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.
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Source: U.S. FDA openFDA. Informational only. RSS feed of new records
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