Data / Medical devices / Holder, Head, Neurosurgical (Skull Clamp) / United States
FDA-registered makers of Holder, Head, Neurosurgical (Skull Clamp) in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Holder, Head, Neurosurgical (Skull Clamp) (product code HBL). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Holder, Head, Neurosurgical (Skull Clamp)
- Product code
- HBL
- Country
- United States
Makers of Holder, Head, Neurosurgical (Skull Clamp) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | Cincinnati, OH, United States | Manufacturer | 14 | November 24, 2014 | 0 | 2 | 0 | api.fda.gov |
| Black Forest Medical North America, Inc. | Cape Coral, FL, United States | Manufacturer | 7 | March 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Integra Pain Management | West Valley City, UT, United States | Manufacturer | 5 | September 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| IMRIS Imaging, Inc. | Chaska, MN, United States | Manufacturer | 3 | September 4, 2014 | 0 | 4 | 0 | api.fda.gov |
| ClearPoint Neuro Inc. | Carlsbad, CA, United States | Manufacturer | 2 | November 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| FHC, Inc. | Bowdoin, ME, United States | Manufacturer | 1 | August 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neuromodulation | Minneapolis, MN, United States | Manufacturer | 1 | August 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Manufacturer, Repackager or relabeler | 1 | August 29, 2000 | 0 | 0 | 0 | api.fda.gov |
| TZ Medical, Inc. | Tualatin, OR, United States | Manufacturer, Specification developer | 1 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Specialteam | Chino, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.