Data / Medical devices / United States / Syntech, Int'l Inc.
Syntech, Int'l Inc.: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
Syntech, Int'l Inc. is registered with the FDA (registration 3005142514) in Irvine, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 18, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005142514
- Address
- 17171 Daimler Ave., Irvine, CA, United States, 92614
- Owner or operator
- SYNTECH, INT'L INC. (2083467)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 6, 2017
- Registered through
- 2026
- Brand names listed
- Surgical Gown, Tube Set, low profile short lens, low profile wrap around lens, short lens sterile, steri-shield face guard, sterishield, sterishield head gear and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Exhaust, Surgical | FYD | 2 | Contract manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2004 | K040485 | MAXAIR SURGICAL HELMET SYSTEM | FYA | Substantially Equivalent | Bio-Medical Devices, Inc. | accessdata.fda.gov |
| July 8, 1988 | K881913 | PROTECTO-SHIELD | FXX | Substantially Equivalent | Syntech Mfg. Services | accessdata.fda.gov |
Compare with other makers
Updated October 18, 2004. 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.