FDA 510(k) Applications Submitted by STERILMED, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K050343 02/11/2005 REPROCESSED HARMONIC SCALPELS STERILMED, INC.
K041127 04/30/2004 MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS STERILMED, INC.
K042648 09/28/2004 REPROCESSED COLD BIOPSY FORCEPS STERILMED, INC.
K043453 12/15/2004 STERILEMED REPROCESSED IVUS IMAGING CATHETER STERILMED, INC.
K050136 01/21/2005 REPROCESSED HOT BIOPSY FORCEPS STERILMED, INC.
K051220 05/12/2005 REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC.
K053188 11/15/2005 REPROCESSED BALOON INFLATION DEVICE STERILMED, INC.
K043513 12/20/2004 STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER STERILMED, INC.
K043592 12/29/2004 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC.
K070859 03/28/2007 REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS STERILMED, INC.
K070930 04/03/2007 REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS STERILMED, INC.
K092158 07/16/2009 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC.
K083060 10/14/2008 REPROCESSED HARMONIC SCALPEL STERILMED, INC.
K063844 12/26/2006 REPROCESSED HEART STABILIZERS AND POSITIONERS STERILMED, INC.
K110076 01/11/2011 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER STERILMED, INC.
K100707 03/12/2010 REPROCESSED PINS STERILMED, INC.
K111002 04/11/2011 REPROCESSED ENDOSCOPIC TROCARS STERILMED, INC.
K101789 06/28/2010 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC.
K092368 08/05/2009 REPROCESSED PULSE OXIMETER SENSORS STERILMED, INC.
K102560 09/07/2010 REPROCESSED PULSE OXIMETER SENSORS STERILMED, INC.
K083636 12/09/2008 REPROCESSED EXTERNAL FIXATION DEVICE STERILMED, INC.
K190478 02/27/2019 Reprocessed ViewFlexÖ Xtra ICE Catheter Sterilmed, Inc.
K190610 03/11/2019 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Sterilmed, Inc.
K182272 08/22/2018 Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis Sterilmed, Inc.
K120040 01/05/2012 REPROCESSED SURGICAL ELECTRIC INSTRUMENT STERILMED, INC.
K120204 01/23/2012 REPROCESSED FEMORAL COMPRESSION DEVICE STERILMED, INC.
K121158 04/16/2012 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC.
K123096 10/02/2012 REPROCESSED VESSEL SEALER STERILMED, INC.
K133414 11/07/2013 REPROCESSED CLOSURE SYSTEM STERILMED, INC.
K121240 04/24/2012 REPROCESSED ENDOSCOPIC TROCARS STERILMED, INC.
K081342 05/13/2008 REPROCESSED EXTERNAL FIXATION ACCESSORIES STERILMED, INC.
K081586 06/05/2008 REPROCESSED EXTERNAL FIXATION DEVICE STERILMED, INC.
K081814 06/26/2008 REPROCESSED ENT SHAVERS STERILMED, INC.
K073613 12/21/2007 REPROCESSED SCISSOR TIPS STERILMED, INC.
K150357 02/12/2015 Reprocessed Electrophysiology Diagnostic Catheters STERILMED, INC.
K143260 11/13/2014 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider STERILMED, INC.
K143562 12/16/2014 Reprocessed Cordless Ultrasonic Dissection Device STERILMED, INC.
K111794 06/27/2011 REPROCESSED HARMONIC SCALPEL STERILMED, INC.
K012678 08/14/2001 REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC.
K161086 04/18/2016 Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Sterilmed, Inc.
K152090 07/27/2015 Reprocessed Steerable Introducer STERILMED, INC.
K152134 07/31/2015 Reprocessed Vessel Sealer STERILMED, INC.
K153006 10/14/2015 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter STERILMED, INC.
K012523 08/06/2001 REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS STERILMED, INC.
K012537 08/07/2001 REPROCESSED IMAGING CATHETERS STERILMED, INC.
K012536 08/07/2001 REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES STERILMED, INC.
K012556 08/08/2001 REPROCESSED GUIDEWIRES STERILMED, INC.
K012579 08/09/2001 REPROCESSED PHACO TIPS STERILMED, INC.
K012574 08/09/2001 REPROCESSED FEMORAL COMPRESSION DEVICE STERILMED, INC.
K012571 08/09/2001 REPROCESSED HARMONIC STERILMED, INC.
K012578 08/09/2001 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC.
K012581 08/09/2001 REPROCESSED STONE RETRIEVAL BASKETS STERILMED, INC.
K012597 08/10/2001 STERILMED REPROCESSED COMPRESSION SLEEVES STERILMED, INC.
K012677 08/14/2001 REPROCESSED PULSE OXIMETER SENSORS STERILMED, INC.
K012679 08/14/2001 REPROCESSED RF ARTHROSCOPY PROBES STERILMED, INC.
K012682 08/14/2001 REPROCESSED LASER PROBE STERILMED, INC.
K012684 08/14/2001 REPROCESSED ELECTROSURGICAL ELECTRODE STERILMED, INC.
K012685 08/14/2001 REPROCESSED ENDOSCOPIC ELECTRODES STERILMED, INC.
K003857 12/13/2000 STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES STERILMED, INC.
K012598 08/10/2001 REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS STERILMED, INC.
K161700 06/20/2016 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters STERILMED, INC.
K132566 08/15/2013 REPROCESSED HARMONIC SHEAR STERILMED, INC.
K052299 08/24/2005 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC.


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