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Ipax, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K200893ProntoPump Sterile Tube SetMay 4, 2021
K971242BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)December 17, 1997
K971245BLINK EXTERNAL EYELID WEIGHTJune 20, 1997
K915158SUREBREATH DOME, E-Z BREATHERFebruary 12, 1992
K915118PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBEDecember 27, 1991
K914172KPE 230 AMOctober 25, 1991
K914221KPE 220 TS, NONSTERILEOctober 25, 1991
K884076SUREBREATH DOMEOctober 7, 1988
K873097PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKSSeptember 4, 1987
K870770TIMLEINE(TM) VENIPUNCTURE SYSTEMApril 23, 1987
K864726I/A/KPE TIPJanuary 20, 1987
K863729OPHTHALMIC FITLER MICRO CAPSULEOctober 10, 1986
K863209US PLUS-PAK(R) SURGICAL SYSTEMSeptember 8, 1986
K862334CATALOG NO. I/A 100 AND KPE 200July 8, 1986
K861182TIMELINE VENIPUNCTURE SYSTEMJune 4, 1986
K860609TIMELINE VENIPUNCTURE SYSTEMJune 4, 1986
K833962KPE PLUS-PAK SURGICAL SYSTEMMarch 12, 1984
K833961I/A PLUS PAK SURGICAL SYSTEMMarch 12, 1984