Data / Medical devices / United States / Crosstex International, Inc.
Crosstex International, Inc.: FDA-registered device maker in Sharon, PA, United States, 1 510(k) clearance
Crosstex International, Inc. is registered with the FDA (registration 3006008984) in Sharon, PA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 1994. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006008984
- Address
- 534 Vine Street, Sharon, PA, United States, 16146
- Owner or operator
- Crosstex International (2433773)
- Roles
- Manufacturer
- First device listed
- October 12, 1995
- Registered through
- 2027
- Brand names listed
- Advantage Saliva Ejector, Air/water Syringe Sleeve, Barrier Film, Combo-TIp, Comfort Plus Premium Saliva Ejector, Duo-Check Sterilization Pouches, MaxVac Plus Combo Tip, PREMIUM SALIVA EJECTORS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | 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 |
|---|---|---|---|---|---|---|
| December 22, 1994 | K941327 | CROSSTEX SELF-SEALING STERILIZATION POUCH | KCT | Substantially Equivalent | Cross Country Paper Products Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthpiece, Saliva Ejector
- All makers of Chair, Dental, Without Operative Unit
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Evacuator, Oral Cavity
- All makers of Bedding, Disposable, Medical
Updated December 22, 1994. 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.