Crosstex International, Inc.
Rush, NY, US
CROSSTEX INTERNATIONAL, INC. appears in FDA device records in Rush, NY. FDA records list 6 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Crosstex International, Inc. between 2008 and 2014. The busiest year on record is 2014, with 3. The most recent is 2014, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140566 | SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE | JOJ | Substantially Equivalent | |
| K140620 | SPORVIEW PLUS BI TEST PACK | FRC | Substantially Equivalent | |
| K133204 | AIRVIEW MINI OWIE DICK TEST PACK | JOJ | Substantially Equivalent | |
| K111343 | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS | FXX | Substantially Equivalent | |
| K103303 | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE | FXX | Substantially Equivalent | |
| K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003675658 | 3003675658 | CROSSTEX INTERNATIONAL, INC. | 621 Hurricane Shoals Rd NW Ste G, LAWRENCEVILLE, GA 30046 US | 2026 | |
| 3006008984 | 3006008984 | CROSSTEX INTERNATIONAL, INC. | 534 VINE STREET, SHARON, PA 16146 US | 2026 | |
| 1319130 | 1319130 | Crosstex International | 6789 WEST HENRIETTA RD., Rush, NY 14543 US | 2026 | and 23 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHRAbsorber, Saliva, Paper
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KXFApplicator, Absorbent Tipped, Non-Sterile
- KMEBedding, Disposable, Medical
- JRGBlock, Heating
- NRUChair, Dental, Without Operative Unit
- FLGCleaner, Ultrasonic, Medical Instrument
- KYWContainer, Liquid Medication, Graduated
- EFNCotton, Roll
- EIEDam, Rubber
- FMADepressor, Tongue, Non-Surgical
- LRJDisinfectant, Medical Devices
- FYEDress, Surgical
- EHZEvacuator, Oral Cavity
- NABGauze / Sponge,Nonresorbable For External Use
- EFAHandpiece, Belt And/Or Gear Driven, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EGZHolder, Film, X-Ray
- FRCIndicator, Biological Sterilization Process
- JOJIndicator, Physical/Chemical Sterilization Process
- EKFInstrument, Contouring, Matrix, Operative
- FXXMask, Surgical
- DYNMouthpiece, Saliva Ejector
- EFHPaper, Articulation
- MSHRespirator, Surgical
- MEDSterilant, Medical Devices
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- KMTTray, Fluoride, Disposable
- EIAUnit, Operative Dental
- NRDUnit, Operative Dental, Accessories
- ECBUnit, Syringe, Air And/Or Water
- LBHVarnish, Cavity
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain