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Meadox Medicals, Div. Boston Scientific Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
53
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGMay 16, 1997
K960766MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFTMarch 19, 1997
K962433MEADOX EXXCEL EPTFE VASCULAR GRAFTMarch 17, 1997
K961847HEMASHIELD VANTAGE (VASCULAR GRAFTJanuary 22, 1997
K962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHSeptember 10, 1996
K955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFTMay 30, 1996
K952884NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETERFebruary 21, 1996
K955349HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRICFebruary 14, 1996
K953298MS CLASSIQUE BALLOON DIATATION CATHETERFebruary 8, 1996
K954848HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFTFebruary 1, 1996
K953608NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETERDecember 20, 1995
K953691MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGOctober 16, 1995
K953332MS CLASSIQUE BALLOON DILATATION CAHTETEROctober 7, 1995
K953597NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETEROctober 7, 1995
K952887NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETERAugust 18, 1995
K943358NAVIGUIDE HYDROPHILIC GUIDE WIREJune 2, 1995
K944989NOPROFILE OLBERT CATHETER SYSTEMApril 26, 1995
K945576MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)January 24, 1995
K945377TRELEX NATURAL(R) MESHDecember 8, 1994
K942635MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEMNovember 1, 1994