Xre Corp.
Littleton, MA, US
Xre Corp. appears in FDA device records in Littleton, MA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Xre Corp. between 1983 and 1997. The busiest year on record is 1985, with 4. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 4 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973744 | UNICATH SP BI-PLANE (MODEL M269 & M289) | JAA | Substantially Equivalent | |
| K961193 | FULL FRAME ZOOM SYSTEM | JAA | Substantially Equivalent | |
| K960998 | XRE COLLIMATOR | IZW | Substantially Equivalent | |
| K945449 | UNICATH LLU ANGIOGRAPHIC SYSTEM | IZI | Substantially Equivalent | |
| K936002 | CINEMAC QAS | IZI | Substantially Equivalent | |
| K933460 | DVFX, MODEL M256 | IZI | Substantially Equivalent | |
| K924828 | BI-N | IZI | Substantially Equivalent | |
| K923654 | POLY DIAGNOST CDX | IZI | Substantially Equivalent | |
| K913685 | UNICATH EP. | IZI | Substantially Equivalent | |
| K912416 | ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM | IZI | Substantially Equivalent | |
| K892849 | UNICATH A | IZI | Substantially Equivalent | |
| K875184 | UNICATH LAB | IZI | Substantially Equivalent | |
| K874114 | TRAUMA TABLE II | IXR | Substantially Equivalent | |
| K874113 | OMNI DIAGNOST | IXR | Substantially Equivalent | |
| K854085 | OMNI PLANE SYSTEM | IXR | Substantially Equivalent | |
| K852952 | TRAUMA STAND | IYB | Substantially Equivalent | |
| K853535 | TRAUMA TABLE | GDC | Substantially Equivalent | |
| K850455 | QUANTIX CARDIAC ANGIOGRAPHIC SYSTEM | IZI | Substantially Equivalent | |
| K837515 | DENTAL CASSETTE HOLDERS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain