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Paragon 28, Inc.

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 612 recall (Z-2971-2026)Paragon 28, Inc.2026-08-14
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6 recall (Z-2972-2026)Paragon 28, Inc.2026-08-14
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZ recall (Z-2758-2026)Paragon 28, Inc.2026-07-17
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S recall (Z-0871-2026)Paragon 28, Inc.2025-12-02
Phantom TTC Nail, 10.0 X 200mm, Right recall (Z-1254-2024)Paragon 28, Inc.2024-03-05
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L recall (Z-1255-2024)Paragon 28, Inc.2024-03-05
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R recall (Z-1256-2024)Paragon 28, Inc.2024-03-05
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use w recall (Z-1776-2022)Paragon 28, Inc.2022-09-22
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size recall (Z-0662-2020)Paragon 28, Inc.2019-12-10

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Every clearance here is in the API, with alerts when new ones post.