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FDA 510(k) clearances and recalls: Neurology devices

23 FDA 510(k) clearances and recalls: Neurology devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22; the most frequent is VPIX Medical, Inc. with 2. 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

Free sample: 3 records (CSV)

23 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22. Most frequent: VPIX Medical, Inc. (2). 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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Records
23
Most frequent
  1. VPIX Medical, Inc. (2)
  2. 7D Surgical ULC (1)
  3. Argus Cognitive, Inc. (1)
  4. Aesculap, Inc. (1)
  5. SurGenTec, LLC (1)

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What are the top FDA 510(k) clearances and recalls: Neurology devices right now?

RecordSpecialtyTypeDate
7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULCNeurology510(k)2026-10-19
cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.Neurology510(k)2026-10-16
Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.Neurology510(k)2026-10-02
Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.Neurology510(k)2026-10-02
cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.Neurology510(k)2026-10-02
Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLCNeurology510(k)2026-09-17
Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.Neurology510(k)2026-09-11
FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.Neurology510(k)2026-10-22
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics LimitedNeurology510(k)2026-10-16
KARL STORZ Flexible Video Neuro-Endoscope (K260581): 510(k) cleared for Karl Storz SE & CO. KGNeurology510(k)2026-10-14
Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLCNeurology510(k)2026-10-09
Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbHNeurology510(k)2026-09-15
TMINI Miniature Robotic System (K263234): 510(k) cleared for THINK Surgical, Inc.Neurology510(k)2026-10-16
CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd.Neurology510(k)2026-10-09
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbHNeurology510(k)2026-09-24
Rongjian Self-adhesive Electrode (K262664): 510(k) cleared for Bozhou Rongjian Medical Appliance Co., Ltd. 🔒 Unlock all 23 records →
Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. 🔒 Unlock all 23 records →
Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd. 🔒 Unlock all 23 records →
Browse 8 more matching record reports

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Which related categories and locations should I check?

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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

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 FDA 510(k) clearances and recalls: Neurology devices are listed?

23 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-22.

Can I get alerts for Neurology?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. RSS feed of new records

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