# Teleflex Medical

- Location (FDA's records): Morrisville, NC
- FDA decisions: 46 (2003–2026): 45 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Teleflex Medical (40); Teleflex Medical, LLC (3); Teleflex Medical Incorporated (3)
- Product codes: GAT (9), FZP (7), FMI (3), GAM (3), BTT (2), EZC (2), BSP (2), BTR (2), MGB (1), GCJ (1), DQX (1), POD (1)
- 510(k) review time since 2016: median 90 days, against 123 for FDA's reviews in the same codes and years (8 of 16 faster)
- Predicates its devices cite: 81 (19 its own); citations of its devices by later devices: 71 (19 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Teleflexmedical, Inc.: 13 (https://510kreport.com/company/teleflexmedical)
- Hudson Respiratory Care, Inc.: 4 (https://510kreport.com/company/hudson-respiratory-care)
- Weck Closure Systems: 4 (https://510kreport.com/company/weck-closure-systems)
- Beere Precision Medical Instruments, Kmedic, Telef: 3 (https://510kreport.com/company/beere-precision-medical-instruments-kmedic-telef)
- Genzyme Surgical Product (Genzyme Biosurgery): 3 (https://510kreport.com/company/genzyme-surgical-product-genzyme-biosurgery)
- Tfx Medical, Inc.: 3 (https://510kreport.com/company/tfx-medical)
- United States Surgical, A Division of Tyco Healthc: 3 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Weck: 3 (https://510kreport.com/company/weck)

## Firms that cite its devices most
- Cayenne Medical, Inc.: 10 (https://510kreport.com/company/cayenne-medical)
- Teleflexmedical, Inc.: 8 (https://510kreport.com/company/teleflexmedical)
- Teleflex, Inc.: 3 (https://510kreport.com/company/teleflex)
- Baylis Medical Co., Inc.: 2 (https://510kreport.com/company/baylis-medical)
- Smith & Nephew, Inc.: 2 (https://510kreport.com/company/smith-nephew)
- Specialized Health Products International, Inc.: 1 (https://510kreport.com/company/specialized-health-products-international)
- Applied Medical Technology, Inc.: 1 (https://510kreport.com/company/applied-medical-technology)
- Dunamis, LLC: 1 (https://510kreport.com/company/dunamis)

## Its most-cited devices
- K063778: Force Fiber Polyethylene Nonabsorbable Suture (2007), cited by 17
- K100506: Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures Model:X-5000FFK, X-5001FFK, X-5002FFK (2010), cited by 8
- K040472: Force Fiber Blue CO-Braided Polyethylene Nonabsorbable Surgical Suture (2004), cited by 8
- K033654: Force Fiber (2004), cited by 7
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (2018), cited by 4
- K082156: Adapt Universal Laparoscopic Port, Model 405940, 405912, 40591213 (2008), cited by 3

## Recent decisions
- K261418: Liquick X-treme, Liquick X-treme Plus (Sep 23, 2026)
- K261988: Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture (Jul 9, 2026)
- K260775: Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (May 6, 2026)
- K251054: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (Jul 3, 2025)
- K242495: LMA Fastrach ETT SU (Apr 29, 2025)
- K243553: QuikClot Control+ Hemostatic Device (Mar 18, 2025)
- K241784: Arrow® Nitinol Wire (Sep 18, 2024)
- K233713: Pilling Tracheostomy Tubes (Mar 22, 2024)

Source page: https://510kreport.com/company/teleflex-medical