Teleflex Medical Orthopedic Fixation Devices

What Teleflex Medical, LLC makes

Teleflex Medical, LLC manufactures orthopedic fixation products, including polyethylene-based materials such as Polyethylene Fusion and Polyethylene OrthoTape™, as well as the MANTA™ Vascular Closure Device for post-procedural hemostasis in vascular access sites.

The company’s portfolio includes devices regulated as Class II and Class III under FDA authorities, with submissions recorded via 510(k) clearances and Premarket Approval Applications (PMA). These products are listed in the FDA’s regulatory databases.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue116

Newest first, rows 101-116 of 116

Search and filter all 116 devices

Weck Efx Endo Fascial Closure System Ref K132362

Active Regimes: 510(k) Registry: 510(k) Class:II
Force Fiber OrthoTape suture Ref K150438

Active Regimes: 510(k) Registry: 510(k) Class:II
Over The Needle Splitable Catheter Assembly Type 1 Ref K920908

Active Regimes: 510(k) Registry: 510(k) Class:II
Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Ref K183461

Active Regimes: 510(k) Registry: 510(k) Class:II
Neonatal ConchaSmart Breathing Circuits Ref K173280

Active Regimes: 510(k) Registry: 510(k) Class:II
Teleflex Rusch SoftSimplastic Foley Catheters Ref K212077

Active Regimes: 510(k) Registry: 510(k) Class:II
Arrow(R) Nextstep Tm Antegrade Chronic Hemodialysis Catheter Ref K102238

Active Regimes: 510(k) Registry: 510(k) Class:II
'cottony' II TAPE, PLEDGETS Ref K153089

Active Regimes: 510(k) Registry: 510(k) Class:II
Telet-Lex Medical Iv Catheter Placement Ref K851142

Active Regimes: 510(k) Registry: 510(k) Class:II
Rusch Tracflex Plus Pediatric Tracheostomy Tube Set Ref K133173

Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k) Class:II
Percuvance(R) Percutaneous Surgical System Ref K143299

Active Regimes: 510(k) Registry: 510(k) Class:II
Pilling Esophageal Bougies Ref K133439

Active Regimes: 510(k) Registry: 510(k) Class:II
UltraCath Continuous Nerve block Catheter Ref K162522

Active Regimes: 510(k) Registry: 510(k) Class:II
Neb-U-Mask System, Models 1895, 1896 Ref K080230

Active Regimes: 510(k) Registry: 510(k) Class:II
Weck Vista Optical Bladeless Laparoscopic Access Port Ref K121380

Active Regimes: 510(k) Registry: 510(k) Class:II
MANTA™ Vascular Closure Device Ref P180025

Active Regimes: PMA Registry: PMA Class:III

Rows 101-116 of 116

Showing 101-116 of 116

Company details

EUDAMED SRN: US-MF-000023660
FDA FEI number: 3005747797
EUDAMED status: Active
EUDAMED registered name: Teleflex Medical LLC.
Registered address: 3015, Carrington Mill Blvd, 27560, Morrisville, United States
Website: teleflex.com/emea/contact/europe-middle-east-africa/
Email: [email protected]
Phone: 353 (0) 9 06 46 08 00
PRRC contact: Marisa Walsh(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 13 Feb 2028

BSI Group The Netherlands B.V. 2797 1 certificate

MDR 752387 Active Supplemented

Quality management system EU MDR

Issued
29 Sep 2026

Expires
13 Feb 2028

Reason
Change approved

Certifiers

BSI Group The Netherlands B.V. 2797

What Teleflex Medical, LLC makes

Catalogue116

Weck Efx Endo Fascial Closure System Ref K132362

Force Fiber OrthoTape suture Ref K150438

Over The Needle Splitable Catheter Assembly Type 1 Ref K920908

Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter Ref K183461

Neonatal ConchaSmart Breathing Circuits Ref K173280

Teleflex Rusch SoftSimplastic Foley Catheters Ref K212077

Arrow(R) Nextstep Tm Antegrade Chronic Hemodialysis Catheter Ref K102238

'cottony' II TAPE, PLEDGETS Ref K153089

Telet-Lex Medical Iv Catheter Placement Ref K851142

Rusch Tracflex Plus Pediatric Tracheostomy Tube Set Ref K133173

Percuvance(R) Percutaneous Surgical System Ref K143299

Pilling Esophageal Bougies Ref K133439

UltraCath Continuous Nerve block Catheter Ref K162522

Neb-U-Mask System, Models 1895, 1896 Ref K080230

Weck Vista Optical Bladeless Laparoscopic Access Port Ref K121380

MANTA™ Vascular Closure Device Ref P180025

Company details

EUDAMED certificates1

BSI Group The Netherlands B.V. 2797 ·1 certificate

Related companies

Certifiers

BSI Group The Netherlands B.V. 2797 1 certificate