Home › Device types › HAW
Neurological Stereotaxic Instrument
FDA product code HAW · Class 2 · Neurology
5,253
Registered devices
42,726
Adverse events
197
Recalls
424
510(k) clearances
Devices with this code
N/A — MEDTRONIC NAVIGATION, INC.N/A — MEDTRONIC NAVIGATION, INC.microTargeting™ Insertion Tube with Stylet — FHC, INC.STar™ Drive Frame Adapter — FHC, INC.N/A — inomed Medizintechnik GmbHN/A — MEDTRONIC NAVIGATION, INC.Guide 3.4 Biopsy Ui — Brainlab SELeksell Stereotactic System — Elekta Solutions ABAdapter For Rectangular Instruments — Brainlab SELeksell Stereotactic System — Elekta Instrument ABStealthStation S8 Platform — MEDTRONIC NAVIGATION, INC.N/A — MEDTRONIC NAVIGATION, INC.Bed Adaptors Kit — MAZOR ROBOTICS LTDStarlink Suction Tube Frazier-Tip 45° Angled 10 FR — Brainlab SELocalite TMS Navigator TS — LOCALITE GmbHIntegra® — INTEGRA LIFESCIENCES CORPORATIONAutoguide — MEDTRONIC NAVIGATION, INC.Navigation Software Spine & Trauma 3D — Brainlab SEAdapter BK-9009 — Brainlab SEEXCELSIUS GPS — GLOBUS MEDICAL, INC.N/A — MEDTRONIC NAVIGATION, INC.K-wires 2.0X120 w/stop, 5 pack — MAZOR ROBOTICS LTDLeksell Stereotactic System Neurosurgical Instruments — Elekta Instrument ABiFuse Navigation Tracking System — Si-Bone Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-19 | Elekta, Inc. | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| 2025-11-12 | Howmedica Osteonics Corp. | When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application |
| 2025-09-30 | Elekta, Inc. | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the |
| 2024-10-04 | FHC, Inc. | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long rela |
| 2024-09-25 | Elekta Instrument AB | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is sta |
| 2024-03-26 | Medtronic Navigation, Inc. | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during na |
| 2024-03-15 | Elekta Instrument AB | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needl |
| 2024-02-26 | Navinetics Inc | Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereo |
| 2023-12-11 | Globus Medical, Inc. | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
| 2023-12-11 | Globus Medical, Inc. | Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.