Bionix Development Corp.

FDA Regulatory Profile

Bionix Development Corp. has 0 FDA recalls, 0 inspections, 13 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 24, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances13Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K180605GastroFlushOct 24, 2018
K153270TruGuard Custom Tongue and Jaw PositionerMar 8, 2016
K123411LITTLE ANGELS SWADDLING BLANKETMar 7, 2013
K120335EMBRACE THERMOPLASTICMay 3, 2012
K100691OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500May 11, 2010
K100264T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060Apr 9, 2010
K050701THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010Apr 1, 2005
K040773PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEMApr 9, 2004
K030051VERSABOARD, MODEL 7040Apr 4, 2003
K933614PITUITARY BOARDOct 7, 1993
K9336133-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZEROct 7, 1993
K905007STANDARD BREAST BOARDS; DELUXE BREAST BOARDFeb 12, 1991
K900370ONE/CIRC (CIRCUMCISION CLAMP)Apr 16, 1990