Company · US
Teleflexmedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2024. Name variants (Inc, Corp, punctuation) are merged.
64510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 5 |
| CAF | Nebulizer (Direct Patient Interface) | 4 |
| DYB | Introducer, Catheter | 4 |
| EZL | Catheter, Retention Type, Balloon | 4 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 4 |
| CAC | Apparatus, Autotransfusion | 3 |
| CBN | Apparatus, Gas-Scavenging | 3 |
| DQX | Wire, Guide, Catheter | 3 |
| MSD | Catheter, Hemodialysis, Implanted | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 |
| CAZ | Anesthesia Conduction Kit | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 2 |
| FZP | Clip, Implantable | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| JOH | Tube Tracheostomy And Tube Cuff | 2 |
| OCW | Endoscopic Tissue Approximation Device | 2 |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 |
| BSO | Catheter, Conduction, Anesthetic | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2024 | K232469 | Rüsch Latex Gold Foley Catheter Teleflexmedical, Inc. | EZL |
| Jul 27, 2023 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters Teleflexmedical, Inc. | EZL |
| Dec 6, 2019 | K192324 | Sheridan Spiral-Flex Endotracheal Tubes Teleflexmedical, Inc. | BTR |
| Jul 1, 2019 | K182847 | Hudson RCI Voldyne Volumetric Exerciser Teleflexmedical, Inc. | BWF |
| May 24, 2019 | K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter Teleflexmedical, Inc. | KOD |
| May 8, 2019 | K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Teleflexmedical, Inc. | GBM |
| Oct 12, 2018 | K181852 | Percuvance Percutaneous Surgical System Teleflexmedical, Inc. | GEI |
| Aug 2, 2018 | K173280 | Neonatal ConchaSmart Breathing Circuits Teleflexmedical, Inc. | BZE |
| Feb 12, 2018 | K172775 | MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle Teleflexmedical, Inc. | OCW |
| May 5, 2017 | K161770 | Rusch Silicone Foley Catheter Teleflexmedical, Inc. | EZL |
| Mar 17, 2017 | K162522 | UltraCath Continuous Nerve block Catheter Teleflexmedical, Inc. | BSO |
| Feb 24, 2017 | K162989 | Rusch Simplastic Foley Catheters Teleflexmedical, Inc. | EZL |
| Jan 19, 2017 | K162242 | Comfort Flo Humidification System Teleflexmedical, Inc. | BTT |
| Nov 23, 2016 | K162396 | SILK Surgical Suture Teleflexmedical, Inc. | GAP |
| Oct 4, 2016 | K161075 | Arrow Epidural Catheter Kit Teleflexmedical, Inc. | CAZ |
| Aug 12, 2016 | K153089 | 'cottony' II TAPE, PLEDGETS Teleflexmedical, Inc. | GAT |
| Jul 26, 2016 | K153010 | Hudson RCI AquaPak Sterile Prefilled Nebulizers Teleflexmedical, Inc. | CAF |
| Jun 16, 2016 | K153076 | silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEE Teleflexmedical, Inc. | GAT |
| Apr 8, 2016 | K153063 | PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM Teleflexmedical, Inc. | GEI |
| Nov 27, 2015 | K150603 | Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Teleflexmedical, Inc. | BTR |
| Aug 26, 2015 | K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflexmedical, Inc. | FZP |
| Jun 26, 2015 | K143581 | Arrow Epidural Catheter Kit Teleflexmedical, Inc. | CAZ |
| May 8, 2015 | K142103 | CUFF PILOT, SURE SEAL Teleflexmedical, Inc. | BSK |
| Apr 29, 2015 | K142153 | HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML Teleflexmedical, Inc. | CAF |
| Apr 15, 2015 | K141888 | RUSCH ENDOBRONCHIAL TUBES Teleflexmedical, Inc. | CBI |
| Apr 2, 2015 | K150438 | Force Fiber OrthoTape suture Teleflexmedical, Inc. | GAT |
| Feb 12, 2015 | K143469 | SOFTECH Plus ETCO2 Cannula Teleflexmedical, Inc. | CCK |
| Jan 21, 2015 | K143299 | Percuvance(R) Percutaneous Surgical System Teleflexmedical, Inc. | GCJ |
| Dec 19, 2014 | K142777 | Weck Hem-o-lok Auto Endo5 Ligating Clip Applier Teleflexmedical, Inc. | FZP |
| Dec 18, 2014 | K141214 | AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS Teleflexmedical, Inc. | CAF |
| Nov 24, 2014 | K141939 | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET Teleflexmedical, Inc. | BTR |
| Oct 30, 2014 | K142138 | ISO-GARD MASK Teleflexmedical, Inc. | CBN |
| Oct 23, 2014 | K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflexmedical, Inc. | CAC |
| Oct 21, 2014 | K140197 | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM Teleflexmedical, Inc. | CAC |
| Aug 1, 2014 | K141353 | HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR Teleflexmedical, Inc. | BTT |
| Jun 16, 2014 | K133439 | PILLING ESOPHAGEAL BOUGIES Teleflexmedical, Inc. | FAT |
| Jun 6, 2014 | K132415 | RUSCH SAFETY SILK SERIES ORAL/NASAL TRACHEAL TUBE Teleflexmedical, Inc. | BTR |
| Jun 4, 2014 | K132946 | SOFTECH PLUS ETC02 CANNULA Teleflexmedical, Inc. | CCK |
| May 23, 2014 | K133173 | RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET Teleflexmedical, Inc. | JOH |
| Jan 9, 2014 | K132729 | ISO-GARD MASK Teleflexmedical, Inc. | CBN |
| Oct 8, 2013 | K132362 | WECK EFX ENDO FASCIAL CLOSURE SYSTEM Teleflexmedical, Inc. | OCW |
| Sep 6, 2013 | K122235 | RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET Teleflexmedical, Inc. | JOH |
| Feb 14, 2013 | K123176 | ISO-GARD CLEARAIR MASK Teleflexmedical, Inc. | CBN |
| Feb 12, 2013 | K130043 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM Teleflexmedical, Inc. | CAC |
| Oct 11, 2012 | K121796 | WECK REUSABLE OBTURATOR Teleflexmedical, Inc. | GCJ |
| May 25, 2012 | K121380 | WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT Teleflexmedical, Inc. | GCJ |
| Nov 18, 2011 | K112554 | TRANSRADIAL ARTERY ACCESS DEVICES Teleflexmedical, Inc. | DYB |
| Oct 4, 2011 | K112456 | ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT Teleflexmedical, Inc. | GCJ |
| Aug 17, 2011 | K111900 | NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER Teleflexmedical, Inc. | MSD |
| Jun 30, 2011 | K111117 | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflexmedical, Inc. | MSD |
Newest 50 of 64.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||