Byron Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K040149PSI-TEC PERISTALTIC INFILTRATION PUMPJune 3, 2004
K001803ACCELERATOR RECIPROCATING CANNULAAugust 4, 2000
K981215PSI-TEC LIPOSUCTION ASPIRATORJuly 1, 1998
K981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESJune 30, 1998
K980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONJune 16, 1998
K980392PSI-TEC ASPIRATORMarch 5, 1998
K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGFebruary 10, 1998
K973133BIG BAG 3000 PRESSURE INFUSORSeptember 12, 1997
K934179DISPOSABLE BAG DECANTERMay 23, 1994
K934233ZARA ZONE IV MALAR IMPLANT MODIFICATIONFebruary 3, 1994
K933670BIOPSY PUNCH, SURGICALJanuary 7, 1994
K913882ZARA SILICONE BLOCKApril 21, 1992
K914016ZARA ZONE IV MALAR IMPLANTDecember 5, 1991
K910436ELASTIC ADHESIVE BANDAGEMarch 19, 1991
K910457ZARA EXTENDED CHIN IMPLANTFebruary 19, 1991
K910456ZARA CHIN IMPLANTFebruary 19, 1991
K910458ZARA SOFT TIP CHIN IMPLANTFebruary 19, 1991
K895865SERENE WRAPDecember 27, 1989
K881460SMOKEVAC ELECTORSURGICAL PENCILMay 4, 1988
K863397BYRON SILICONE CHIN IMPLANTSSeptember 18, 1986