Medical Device Manufacturer · US , Plymouth , MN

Sterilmed, Inc. - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 2001
64
Total
64
Cleared
0
Denied

FDA 510(k) cleared devices by Sterilmed, Inc. Cardiovascular

22 devices
1-22 of 22
Cleared Oct 11, 2024
Reprocessed DECANAV™ Electrophysiology Catheter
K240826 · NLH
Cardiovascular · 199d
Cleared Nov 14, 2019
Reprocessed ViewFlex™ Xtra ICE Catheter
K190478 · OWQ
Cardiovascular · 260d
Cleared Nov 21, 2016
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G...
K161700 · OWQ
Cardiovascular · 154d
Cleared Jun 23, 2016
Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology...
K153006 · NLH
Cardiovascular · 253d
Cleared Mar 23, 2016
Reprocessed Steerable Introducer
K152090 · PNE
Cardiovascular · 240d
Cleared Aug 27, 2015
Reprocessed Electrophysiology Diagnostic Catheters
K150357 · NLH
Cardiovascular · 196d
Cleared Aug 06, 2012
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · NLH
Cardiovascular · 112d
Cleared Apr 03, 2012
REPROCESSED FEMORAL COMPRESSION DEVICE
K120204 · NMF
Cardiovascular · 71d
Cleared Aug 18, 2011
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
K110076 · OWQ
Cardiovascular · 219d
Cleared Aug 19, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K101789 · NLH
Cardiovascular · 52d
Cleared Jan 14, 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K092158 · NLH
Cardiovascular · 182d
Cleared Mar 15, 2007
REPROCESSED HEART STABILIZERS AND POSITIONERS
K063844 · NQG
Cardiovascular · 79d
Cleared May 04, 2006
REPROCESSED BALOON INFLATION DEVICE
K053188 · NKU
Cardiovascular · 170d
Cleared Jun 14, 2005
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K051220 · NLH
Cardiovascular · 33d
Cleared Mar 01, 2005
STERILEMED REPROCESSED IVUS IMAGING CATHETER
K043453 · OWQ
Cardiovascular · 76d
Cleared Mar 01, 2005
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
K043513 · NLH
Cardiovascular · 71d
Cleared Oct 11, 2002
REPROCESSED IMAGING CATHETERS
K012537 · OWQ
Cardiovascular · 430d
Cleared Aug 14, 2002
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012523 · NLH
Cardiovascular · 373d
Cleared Aug 14, 2002
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K012678 · NLH
Cardiovascular · 365d
Cleared Jul 18, 2002
REPROCESSED FEMORAL COMPRESSION DEVICE
K012574 · NMF
Cardiovascular · 343d
Cleared Feb 11, 2002
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · JOW
Cardiovascular · 185d
Cleared Oct 18, 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · JOW
Cardiovascular · 309d
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