Data / Medical devices / Holder, Head, Neurosurgical (Skull Clamp)
Holder, Head, Neurosurgical (Skull Clamp) (HBL): 20 FDA-registered makers in 3 countries
20 establishments in 3 countries are registered with the FDA to make Holder, Head, Neurosurgical (Skull Clamp) (product code HBL, Class 2, 21 CFR 882.4460). 13 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 50 510(k) clearances under this code, the latest on November 6, 2025, and lists 12 recall events (1 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- HBL
- Device class
- 2
- Regulation
- 882.4460
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 8 |
| Japan | 1 |
Makers of Holder, Head, Neurosurgical (Skull Clamp)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 GmbH | FREIBURG Baden-Wurttemberg, Germany | Manufacturer | 8 | April 24, 2024 | 0 | 3 | 1 | 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 |
| MIZUHO Corporation Gosen Factory | Gosen Niigata, Japan | Manufacturer | 2 | September 12, 1996 | 0 | 0 | 0 | api.fda.gov |
| Brainlab Se | Munich Bavaria, Germany | Manufacturer | 1 | April 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| FHC, Inc. | Bowdoin, ME, United States | Manufacturer | 1 | August 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Medical Bees GMBH | Emmingen-Liptingen Baden-Wurttemberg, Germany | Manufacturer | 1 | November 6, 2025 | 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 |
| Eurofins Inpac Medizintechnik GMBH | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins Inpac Medizintechnik GMBH | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NORAS MRI products GMBH | HOECHBERG Bavaria, Germany | Contract manufacturer, Manufacturer | 0 | 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 | |
| Siemens Healthineers AG | ERLANGEN Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 6, 2025. 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.