Medical Device Manufacturer · US , Jeffrey , NH

Teleflexmedical, Inc.

64 submissions · 61 cleared · Since 1985
64
Total
61
Cleared
0
Denied

Teleflexmedical, Inc. — FDA 510(k) Submissions

Teleflexmedical, Inc. has submitted 64 FDA 510(k) premarket notifications since 1985, of which 61 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Laparoscope, General & Plastic Surgery, Tube, Tracheal (w/wo Connector), Introducer, Catheter, Catheter, Retention Type, Balloon, Suture, Nonabsorbable, Synthetic, Polyethylene . Use the specialty filter in the sidebar to narrow results.

64 devices
1–25 of 64
R?sch Latex Gold Foley Catheter
K232469 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Aug 2024 352d
Teleflex Rusch SoftSimplastic Foley Catheters
K212077 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Jul 2023 755d
Sheridan Spiral-Flex Endotracheal Tubes
K192324 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Dec 2019 101d
Hudson RCI Voldyne Volumetric Exerciser
K182847 · BWF Spirometer, Therapeutic... · Anesthesiology
Jul 2019 265d
Rusch FloCath Quick 18 Fr. Coud? Hydrophilic Intermittent Catheter
K181979 · KOD Catheter, Urological · Gastroenterology & Urology
May 2019 303d
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
K183461 · GBM Catheter, Urethral · Gastroenterology & Urology
May 2019 145d
Percuvance Percutaneous Surgical System
K181852 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2018 93d
Neonatal ConchaSmart Breathing Circuits
K173280 · BZE Heater, Breathing System... · Anesthesiology
Aug 2018 290d
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · OCW Endoscopic Tissue... · Gastroenterology & Urology
Feb 2018 151d
Rusch Silicone Foley Catheter
K161770 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
May 2017 311d
UltraCath Continuous Nerve block Catheter
K162522 · BSO Catheter, Conduction,... · Anesthesiology
Mar 2017 189d
Rusch Simplastic Foley Catheters
K162989 · EZL Catheter, Retention Type,... · Gastroenterology & Urology
Feb 2017 120d
Comfort Flo Humidification System
K162242 · BTT Humidifier, Respiratory... · Anesthesiology
Jan 2017 162d
SILK Surgical Suture
K162396 · GAP Suture, Nonabsorbable, Silk · General & Plastic Surgery
Nov 2016 89d
Arrow Epidural Catheter Kit
K161075 · CAZ Anesthesia Conduction Kit · Anesthesiology
Oct 2016 169d
'cottony' II TAPE, PLEDGETS
K153089 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Aug 2016 291d
Hudson RCI AquaPak Sterile Prefilled Nebulizers
K153010 · CAF Nebulizer (direct Patient... · Anesthesiology
Jul 2016 286d
silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL
K153076 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Jun 2016 237d
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM
K153063 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2016 169d
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
K150603 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Nov 2015 262d
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
K152081 · FZP Clip, Implantable · General & Plastic Surgery
Aug 2015 30d
Arrow Epidural Catheter Kit
K143581 · CAZ Anesthesia Conduction Kit · Anesthesiology
Jun 2015 190d
CUFF PILOT, SURE SEAL
K142103 · BSK Cuff, Tracheal Tube,... · Anesthesiology
May 2015 280d
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML
K142153 · CAF Nebulizer (direct Patient... · Anesthesiology
Apr 2015 266d
RUSCH ENDOBRONCHIAL TUBES
K141888 · CBI Tube, Tracheal/bronchial,... · Anesthesiology
Apr 2015 275d
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