FDA 510(k) Applications Submitted by TELEFLEX MEDICAL, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K161075 04/18/2016 Arrow Epidural Catheter Kit TELEFLEX MEDICAL, INC.
K101671 06/14/2010 SINGLE SITE FLEXIBLE BLADELESS OBTURATOR Teleflex Medical, Inc.
K132729 09/03/2013 ISO-GARD MASK Teleflex Medical, Inc.
K132946 09/19/2013 SOFTECH PLUS ETC02 CANNULA Teleflex Medical, Inc.
K123176 10/10/2012 ISO-GARD CLEARAIR MASK Teleflex Medical, Inc.
K143581 12/18/2014 Arrow Epidural Catheter Kit Teleflex Medical, Inc.
K152081 07/27/2015 Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflex Medical, Inc.
K142777 09/26/2014 Weck Hem-o-lok Auto Endo5 Ligating Clip Applier Teleflex Medical, Inc.
K142138 08/05/2014 ISO-GARD MASK Teleflex Medical, Inc.
K153010 10/14/2015 Hudson RCI AquaPak Sterile Prefilled Nebulizers Teleflex Medical, Inc.
K143469 12/05/2014 SOFTECH Plus ETCO2 Cannula TELEFLEX MEDICAL, INC.
K112554 09/02/2011 TRANSRADIAL ARTERY ACCESS DEVICES Teleflex Medical, Inc.
K070673 03/12/2007 FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE Teleflex Medical, Inc.
K172775 09/14/2017 MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle Teleflex Medical, Inc.
K153063 10/22/2015 PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM Teleflex Medical, Inc.
K143299 11/17/2014 Percuvance(R) Percutaneous Surgical System Teleflex Medical, Inc.
K140197 01/27/2014 PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflex Medical, Inc.
K140205 01/27/2014 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflex Medical, Inc.
K121796 06/19/2012 WECK REUSABLE OBTURATOR Teleflex Medical, Inc.
K133439 11/12/2013 PILLING ESOPHAGEAL BOUGIES Teleflex Medical, Inc.
K141214 05/12/2014 AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS Teleflex Medical, Inc.
K141939 07/17/2014 TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET Teleflex Medical, Inc.
K142153 08/06/2014 HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML Teleflex Medical, Inc.
K212077 07/02/2021 Teleflex Rusch SoftSimplastic Foley Catheters Teleflex Medical, Inc.
K181852 07/11/2018 Percuvance Percutaneous Surgical System Teleflex Medical, Inc.
K150603 03/10/2015 Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Teleflex Medical, Inc.
K161770 06/28/2016 Rusch Silicone Foley Catheter Teleflex Medical, Inc.
K141888 07/14/2014 RUSCH ENDOBRONCHIAL TUBES Teleflex Medical, Inc.
K122235 07/26/2012 RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET Teleflex Medical, Inc.
K132415 08/02/2013 RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE Teleflex Medical, Inc.
K133173 10/17/2013 RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET Teleflex Medical, Inc.
K162989 10/27/2016 Rusch Simplastic Foley Catheters TELEFLEX MEDICAL, INC.
K132362 07/30/2013 WECK EFX ENDO FASCIAL CLOSURE SYSTEM Teleflex Medical, Inc.
K153076 10/23/2015 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL Teleflex Medical, Inc.
K153089 10/26/2015 'cottony' II TAPE, PLEDGETS Teleflex Medical, Inc.
K130043 01/08/2013 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM Teleflex Medical, Inc.
K121380 05/08/2012 WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT Teleflex Medical, Inc.
K112456 08/25/2011 ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT Teleflex Medical, Inc.
K080230 01/30/2008 NEB-U-MASK SYSTEM, MODELS 1895, 1896 Teleflex Medical, Inc.
K142103 08/01/2014 CUFF PILOT, SURE SEAL Teleflex Medical, Inc.
K181979 07/25/2018 Rusch FloCath Quick 18 Fr. CoudΘ Hydrophilic Intermittent Catheter Teleflex Medical, Inc.
K111117 04/21/2011 CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflex Medical, Inc.
K111900 07/05/2011 NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflex Medical, Inc.
K102238 08/09/2010 ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflex Medical, Inc.
K150438 02/19/2015 Force Fiber OrthoTape suture TELEFLEX MEDICAL, INC.
K091761 06/16/2009 TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT Teleflex Medical, Inc.


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