Data / Medical devices / Motor, Drill, Electric
Motor, Drill, Electric (HBC): 33 FDA-registered makers in 12 countries
33 establishments in 12 countries are registered with the FDA to make Motor, Drill, Electric (product code HBC, Class 2, 21 CFR 882.4360). 10 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on September 11, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HBC
- Device class
- 2
- Regulation
- 882.4360
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 17 |
| Switzerland | 3 |
| Malaysia | 3 |
| Japan | 2 |
| Germany | 1 |
| South Korea | 1 |
| Nicaragua | 1 |
| Mexico | 1 |
| Dominican Republic | 1 |
| Romania | 1 |
| China | 1 |
| United Kingdom | 1 |
Makers of Motor, Drill, Electric
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, Specification developer | 4 | May 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 3 | July 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 3 | May 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| The Anspach Effort, Inc. | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | May 19, 2022 | 0 | 10 | 0 | api.fda.gov |
| Bien-Air Surgery SA | Le Noirmont Jura, Switzerland | Foreign private label distributor, Manufacturer, Specification developer | 2 | October 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | March 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 2 | May 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nakanishi Inc. | Kanuma Tochigi, Japan | Manufacturer | 2 | December 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | Manufacturer | 2 | September 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 1 | May 12, 2019 | 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 | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Force Engineering Co.ltd | Utsunomiya Tochigi, Japan | 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 | |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millennium Utility SRL | Marmatiei, Romania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nico Corporation | Indianapolis, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nouvag AG | GOLDACH Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rainbow Technology Co.,ltd | Shenzhen Guangdong, China | 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 Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zethon Ltd | ASTON CLINTON Buckinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 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.