Medamicus, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K040150MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCERFebruary 18, 2004
K030905MEDAMICUS FLOWGUARD PEELABLE INTRODUCERApril 9, 2003
K022689MODIFICATION TO MEDAMICUS AXIA RSNAugust 23, 2002
K021004VALVED PEELABLE INTRODUCERJune 6, 2002
K020563MEDAMICUS AXIA RSNMay 21, 2002
K013120PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18January 24, 2002
K011085GUIDEWIRE INTRODUCER SAFETY NEEDLEJuly 9, 2001
K000824PERCUTANEOUS INTRODUCER, MODEL 10383-XXXApril 13, 2000
K994097MEDAMICUS EPIDURAL INTRODUCERMarch 1, 2000
K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETJune 28, 1999
K965167PERCUTANEOUS VENOUS INTRODUCER 10264July 25, 1997
K971911LUMAX CYSTOMETRY ADMINISTRATION TUBE SETJune 3, 1997
K953734LUMAX(MODIFICATION)January 18, 1996
K954093LUMAX (MODIFICATION)January 11, 1996
K951313MEDAMICUS PERCUTANEOUS INTRODUCERJune 27, 1995
K944107VIP PLUS PERCUTANEOUS INTRODUCERSeptember 14, 1994
K932323PERCUTANEOUS INTRODUCERNovember 9, 1993
K920580TRANSDUCER, PRESSURE, CATHETER TIPJanuary 7, 1993
K924491INTRODUCER, PERCUTANEOUS -- MODIFICATIONNovember 18, 1992
K893658PERCUTANEOUS INTRODUCERAugust 3, 1989