Medical Device Manufacturer · US , Fall River , MA

Teleflex Medical

39 submissions · 39 cleared · Since 2003
39
Total
39
Cleared
0
Denied

Teleflex Medical — FDA 510(k) Submissions

Teleflex Medical has submitted 39 FDA 510(k) premarket notifications since 2003, of which 39 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Clip, Implantable, Suture, Nonabsorbable, Synthetic, Polyethylene, Needle, Hypodermic, Single Lumen, Suture, Absorbable, Synthetic, Polyglycolic Acid, Needle, Conduction, Anesthetic (w/wo Introducer) . Use the specialty filter in the sidebar to narrow results.

39 devices
1–25 of 39
Hem-o-lok? PurplePlus? Large Polymer Ligating Clips
K251054 · FZP Clip, Implantable · General & Plastic Surgery
Jul 2025 90d
LMA Fastrach ETT SU
K242495 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Apr 2025 250d
QuikClot Control+ Hemostatic Device
K243553 · POD Temporary, Internal Use... · General & Plastic Surgery
Mar 2025 120d
Arrow? Nitinol Wire
K241784 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2024 90d
Pilling Tracheostomy Tubes
K233713 · BTO Tube, Tracheostomy (w/wo... · Anesthesiology
Mar 2024 123d
Hem-o-lok? Ligating Clips
K232970 · FZP Clip, Implantable · General & Plastic Surgery
Jan 2024 113d
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
K230603 · BSO Catheter, Conduction,... · Anesthesiology
Aug 2023 180d
EZ-IO Intraosseous Vascular Access System
K231924 · FMI Needle, Hypodermic,... · General Hospital
Jul 2023 25d
Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
K230480 · FZP Clip, Implantable · General & Plastic Surgery
Apr 2023 65d
Rusch Intermittent Urethral Catheters
K222279 · EZC Catheter, Coude · Gastroenterology & Urology
Aug 2022 31d
EZ-IO Intraosseous Vascular Access System
K202492 · FMI Needle, Hypodermic,... · General Hospital
Mar 2021 203d
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
K192490 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Mar 2020 201d
Deklene MAXX
K193530 · GAW Suture, Nonabsorbable,... · General & Plastic Surgery
Mar 2020 90d
Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
K190026 · BSP Needle, Conduction,... · Anesthesiology
Aug 2019 226d
Sheridan Endobronchial Tubes
K180253 · CBI Tube, Tracheal/bronchial,... · Anesthesiology
Nov 2018 276d
StimuQuik 21G x 9cm (3.5?) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5?) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6?) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6?) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1?) Peripheral Nerve Block Needle
K173321 · BSP Needle, Conduction,... · Anesthesiology
Apr 2018 187d
FAST1? Intraosseous Infusion System; FASTResponder? Sternal Intraosseous Device
K180588 · FMI Needle, Hypodermic,... · General Hospital
Apr 2018 42d
Rusch Intermittent Urethral Catheters
K173596 · EZC Catheter, Coude · Gastroenterology & Urology
Jan 2018 69d
Weck Auto Endo10 Automatic Endoscopic Clip Applier
K161758 · FZP Clip, Implantable · General & Plastic Surgery
Sep 2016 72d
MADgic Laryngo-Tracheal Mucosal Atomization Device
K153470 · CCT Applicator... · Anesthesiology
Aug 2016 261d
HEM-O-LOK LIGATING CLIP
K133202 · FZP Clip, Implantable · General & Plastic Surgery
Dec 2013 47d
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
K132658 · FZP Clip, Implantable · General & Plastic Surgery
Nov 2013 93d
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET
K130405 · BWC Needle, Emergency Airway · Anesthesiology
Nov 2013 260d
HUMID-VENT HEPA
K112958 · CAH Filter, Bacterial,... · General Hospital
Sep 2012 352d
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
K100506 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Mar 2010 16d
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