Xre Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K973744UNICATH SP BI-PLANE (MODEL M269 & M289)December 29, 1997
K961193FULL FRAME ZOOM SYSTEMJune 17, 1996
K960998XRE COLLIMATORApril 3, 1996
K945449UNICATH LLU ANGIOGRAPHIC SYSTEMFebruary 27, 1995
K936002CINEMAC QASSeptember 9, 1994
K933460DVFX, MODEL M256April 7, 1994
K924828BI-NDecember 17, 1992
K923654POLY DIAGNOST CDXNovember 20, 1992
K913685UNICATH EP.November 7, 1991
K912416ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEMAugust 28, 1991
K892849UNICATH AAugust 9, 1989
K875184UNICATH LABJanuary 29, 1988
K874114TRAUMA TABLE IINovember 16, 1987
K874113OMNI DIAGNOSTNovember 16, 1987
K854085OMNI PLANE SYSTEMOctober 28, 1985
K852952TRAUMA STANDSeptember 26, 1985
K853535TRAUMA TABLESeptember 11, 1985
K850455QUANTIX CARDIAC ANGIOGRAPHIC SYSTEMMay 6, 1985
K837515DENTAL CASSETTE HOLDERSJune 28, 1983
K761339RADIAL TRAVEL SPEC. PROCEDURES TABLEJanuary 5, 1977