Data / Medical devices / Motor, Drill, Pneumatic
Motor, Drill, Pneumatic (HBB): 29 FDA-registered makers in 8 countries
29 establishments in 8 countries are registered with the FDA to make Motor, Drill, Pneumatic (product code HBB, Class 2, 21 CFR 882.4370). 13 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on March 6, 2026, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HBB
- Device class
- 2
- Regulation
- 882.4370
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 16 |
| Switzerland | 3 |
| Malaysia | 3 |
| Germany | 2 |
| Ireland | 2 |
| Turkey | 1 |
| Nicaragua | 1 |
| United Kingdom | 1 |
Makers of Motor, Drill, Pneumatic
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Powered Surgical Solutions | Fort Worth, TX, United States | Manufacturer | 3 | March 23, 2017 | 0 | 8 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 3 | May 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 2 | November 9, 2018 | 0 | 1 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 2 | April 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| The Anspach Effort, Inc. | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | April 14, 2010 | 0 | 3 | 0 | api.fda.gov |
| Adeor Medical AG | Valley Bavaria, Germany | Complaint file establishment, Specification developer | 1 | March 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 1 | March 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 1 | August 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 1 | August 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi | Istanbul, Turkey | Exporter to the US, Manufacturer | 1 | March 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer | 1 | April 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork(County), Ireland | Specification developer | 1 | October 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | April 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Nicaragua SA | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Ireland Ltd., Instruments Division | CARRIGTWOHILL, CO.CORK Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vaupell Midwest Molding and Tooling | Constantine, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zethon Ltd | ASTON CLINTON Buckinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 6, 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.