Data / Medical devices / Apparatus, Exhaust, Surgical
Apparatus, Exhaust, Surgical (FYD): 42 FDA-registered makers in 10 countries
42 establishments in 10 countries are registered with the FDA to make Apparatus, Exhaust, Surgical (product code FYD, Class 2, 21 CFR 878.5070). 23 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 75 510(k) clearances under this code, the latest on August 5, 2024, and lists 9 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- FYD
- Device class
- 2
- Regulation
- 878.5070
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 25 |
| Mexico | 4 |
| China | 4 |
| Malaysia | 3 |
| South Korea | 1 |
| United Kingdom | 1 |
| Switzerland | 1 |
| Poland | 1 |
| Canada | 1 |
| Taiwan | 1 |
Makers of Apparatus, Exhaust, Surgical
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 |
|---|---|---|---|---|---|---|---|---|
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 11 | August 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 4 | March 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer, Manufacturer | 4 | August 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| I.C. Medical, Inc. | Phoenix, AZ, United States | Manufacturer | 4 | October 30, 2017 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Boulder, CO, United States | Manufacturer, Repackager or relabeler | 3 | January 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 2 | January 14, 2015 | 0 | 0 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 2 | February 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Acuderm, Inc. | Fort Lauderdale, FL, United States | Manufacturer | 1 | February 9, 1994 | 0 | 0 | 0 | api.fda.gov |
| Bio Protech Yantai Inc | Yantai Shandong, China | Manufacturer | 1 | August 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bio Protech, Inc. | Wonju-si Gangwon, South Korea | Manufacturer | 1 | August 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, Inc. | Cincinnati, OH, United States | Specification developer | 1 | June 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ethicon Endo-Surgery, LLC | Guaynabo, PR, United States | Specification developer | 1 | June 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Global Life Sciences Solutions USA LLC | Marlborough, MA, United States | Complaint file establishment, Specification developer | 1 | August 20, 1999 | 0 | 0 | 0 | api.fda.gov |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer | 1 | August 12, 1991 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 1 | January 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Megadyne Medical Products, Inc. | Cincinnati, OH, United States | Specification developer | 1 | June 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medrange Corporation | Brea, CA, United States | Specification developer | 1 | April 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Distribution Center | Memphis, TN, United States | Manufacturer | 1 | June 29, 1998 | 0 | 0 | 0 | api.fda.gov |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 1 | March 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pall Newquay | Newquay Cornwall, United Kingdom | Manufacturer | 1 | August 20, 1999 | 0 | 0 | 0 | api.fda.gov |
| Pall International, Sarl | Fribourg, Switzerland | Exporter to the US, Specification developer | 1 | August 20, 1999 | 0 | 0 | 0 | api.fda.gov |
| SurgiSmoke Solutions | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 1 | September 28, 1989 | 0 | 1 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | August 28, 1995 | 0 | 0 | 0 | api.fda.gov |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clunas AG | Tarnowo Podgorne Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed Surgical | Mississauga Ontario, Canada | Contract manufacturer | 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 | |
| Jabil Inc. | Auburn Hills, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Deantronics Taiwan Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ocp De Mexico De Mexico S.A. De C.V. | Tijuana Baja California, Mexico | 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 Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syntech, Int'l Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tessy Plastics Corp. | Elbridge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultraviolet Devices, Inc. | Valencia, CA, 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 | |
| WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | HuiZhou Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. | Huizhou Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Shuyou Surgical Instrument Co., Ltd | Huzhou Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 5, 2024. 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.