Data / Medical devices / Saw, Powered, And Accessories
Saw, Powered, And Accessories (HAB): 47 FDA-registered makers in 11 countries
47 establishments in 11 countries are registered with the FDA to make Saw, Powered, And Accessories (product code HAB, Class 1, 21 CFR 878.4820). 1 of them has a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 19, 2001, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HAB
- Device class
- 1
- Regulation
- 878.4820
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 26 |
| Germany | 7 |
| Switzerland | 3 |
| Mexico | 2 |
| China | 2 |
| Austria | 2 |
| Spain | 1 |
| United Kingdom | 1 |
| India | 1 |
| Japan | 1 |
| South Korea | 1 |
Makers of Saw, Powered, And Accessories
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 |
|---|---|---|---|---|---|---|---|---|
| Linvatec Corporation | Largo, FL, United States | Manufacturer, Specification developer | 1 | October 19, 2001 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alira Medical Devices LLC | Rancho Cucamonga, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex GmbH | Munich Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baeramed Instrumente GMBH | SCHWENNINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Celestica | Valencia Valencia(Province), Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contract Medical Manufacturing, LLC | Oxford, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Intl., Ltd. | Leeds, United Kingdom | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Kaiser Technology Co., Ltd | Dongguan city Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heinrich Medizintechnik GMBH | Stuttgart Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manman Manufacturing Company Private Limited | Pune Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Solutions GMBH | Emmingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micutec AG | Zug, Switzerland | Specification developer | 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 | |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nakanishi Inc. | Kanuma Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nouvag AG | GOLDACH Sankt Gallen, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Princeton Medical Group, Inc. | Franklin, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Saeshin Precision Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Medical Instruments (group) Ltd. Corp. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 1 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, 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 | |
| W&H Dentalwerk Buermoos GMBH | BUERMOOS Salzburg, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| W&H Dentalwerk Buermoos GMBH - Site 2 | BUERMOOS Salzburg, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Surgical SA | 1228 Plan Les Ouates Geneve, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Surgical, Inc. | Dover, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov |
Updated October 19, 2001. 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.