Medamicus, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER, MEDAMICUS FLOWGUARD PEELABLE INTRODUCER, MODIFICATION TO MEDAMICUS AXIA RSN
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medamicus, Inc. Cardiovascular ✕
15 devices
Cleared
Feb 18, 2004
MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
Cardiovascular
26d
Cleared
Apr 09, 2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
Cardiovascular
16d
Cleared
Aug 23, 2002
MODIFICATION TO MEDAMICUS AXIA RSN
Cardiovascular
10d
Cleared
Jun 06, 2002
VALVED PEELABLE INTRODUCER
Cardiovascular
70d
Cleared
May 21, 2002
MEDAMICUS AXIA RSN
Cardiovascular
90d
Cleared
Jul 09, 2001
GUIDEWIRE INTRODUCER SAFETY NEEDLE
Cardiovascular
90d
Cleared
Apr 13, 2000
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
Cardiovascular
30d
Cleared
Jun 28, 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL...
Cardiovascular
116d
Cleared
Jul 25, 1997
PERCUTANEOUS VENOUS INTRODUCER 10264
Cardiovascular
213d
Cleared
Jun 27, 1995
MEDAMICUS PERCUTANEOUS INTRODUCER
Cardiovascular
96d
Cleared
Sep 14, 1994
VIP PLUS PERCUTANEOUS INTRODUCER
Cardiovascular
22d
Cleared
Nov 09, 1993
PERCUTANEOUS INTRODUCER
Cardiovascular
182d
Cleared
Jan 07, 1993
TRANSDUCER, PRESSURE, CATHETER TIP
Cardiovascular
332d
Cleared
Nov 18, 1992
INTRODUCER, PERCUTANEOUS -- MODIFICATION
Cardiovascular
90d
Cleared
Aug 03, 1989
PERCUTANEOUS INTRODUCER
Cardiovascular
80d