10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·August 3, 2022
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·December 10, 2025
Phantom TTC Nail, 10.0 X 200mm, Right
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·March 13, 2024
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·March 13, 2024
Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·March 13, 2024
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·August 3, 2022
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
FDA Enforcement
Class II
·Terminated·Paragon 28, Inc.·September 29, 2021
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
FDA Enforcement
Class II
·Terminated·Paragon 28, Inc.·June 27, 2018
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
FDA Enforcement
Class II
·Terminated·Paragon 28, Inc.·December 18, 2019
Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
FDA Enforcement
Class II
·Ongoing·Paragon 28, Inc.·September 28, 2022