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FDA 510(k) Applications Submitted by Karyl Haskell
FDA 510(k) Number
Submission Date
Device Name
Applicant
K040150
01/23/2004
MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
MEDAMICUS, INC.
K200642
03/11/2020
OrthAlign Plus System
OrthAlign, Inc.
K120796
03/15/2012
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
SUPERDIMENSION INC.
K030905
03/24/2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
MEDAMICUS, INC.
K021004
03/28/2002
VALVED PEELABLE INTRODUCER
MEDAMICUS, INC.
K200892
04/03/2020
Harvey(R) Surgical Assistant
OrthAlign Inc
K041708
06/23/2004
ENPATH SAFETY INTRODUCER
ENPATH MEDICAL INCORPORATED
K022689
08/13/2002
MODIFICATION TO MEDAMICUS AXIA RSN
MEDAMICUS, INC.
K020563
02/20/2002
MEDAMICUS AXIA RSN
MEDAMICUS, INC.
K043489
12/17/2004
ENPATH DEFLECTABLE CATHETER
ENPATH MEDICAL INCORPORATED
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