Data / Medical devices / Drill, Bone, Powered / United States
FDA-registered makers of Drill, Bone, Powered in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Drill, Bone, Powered (product code DZI). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Drill, Bone, Powered
- Product code
- DZI
- Country
- United States
Makers of Drill, Bone, Powered in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Implant Direct Sybron Manufacturing LLC | Thousand Oaks, CA, United States | Manufacturer | 2 | August 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Electro Medical Systems, L.L.C. | Southlake, TX, United States | Remanufacturer, Repackager or relabeler | 1 | December 18, 2007 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Manufacturer | 1 | November 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Manufacturer | 1 | August 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | August 8, 2003 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| The Anspach Effort, Inc. | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 1 | April 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Asi Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolase MG LLC | Corona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolase MG LLC | Foothill Ranch, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nobel Biocare Procera, LLC | Mahwah, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | 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 |
Updated November 2, 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.