Argon Medical Devices, Inc.
Argon Medical Devices, Inc. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2026, with 50 FDA device recalls on record.
Top product codes for Argon Medical Devices, Inc.
FDA recalls by Argon Medical Devices, Inc.
10 most recent of 50- Z-2804-2026 — L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
- Z-2803-2026 — L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463
- Z-2706-2026 — General Biospy Tray, REF: GUTS1000
- Z-2708-2026 — Arterial Line Kit 20ga x 6, REF: 400115A
- Z-2704-2026 — Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- Z-2705-2026 — One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- Z-2707-2026 — T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
- Z-2709-2026 — Bone Marrow Tray, REF: CB0033TL; CB0355TLA
- Z-0589-2026 — Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
- Z-3192-2024 — BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Argon Medical Devices, Inc.
- K252795 — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more
- K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- K251318 — VariFuse Adjustable Infusion Catheter
- K253741 — VStick Vascular Access Set
- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K241145 — TLAB® Transvenous Liver Biopsy System (TF-18C)
- K233909 — Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Handpiece with Maceration Wire, Cleaner Plus 18F Aspiration Canister
- K232679 — Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspiration Canister
- K233432 — 10F Sheath and Dilator Set
- K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- K223176 — Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister
- K211798 — Cleaner Plus Thrombectomy System
- K202141 — Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
- K200963 — Halo Single-Loop Microsnare Kit
- K201489 — Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
- K200268 — Halo Single-Loop Snare Kit
- K191758 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- K160785 — Worker Guidewire
- K141969 — FIRSTSTIC N INTRODUCER
- K070384 — ARGON CONTINUOUS FLUSH DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.