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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