Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

59 results for "Paragon 28, Inc."
1–24 of 59
Search insights Median review: 85d Cleared: 100% Top manufacturer: Paragon 28, Inc. Lead specialty: Orthopedic
Cleared Oct 07, 2026
APEX 3D S Diamond Tibia
K261120 · HSN
Paragon 28, Inc.
Orthopedic · 187d
Cleared Aug 28, 2026
Primal K-Wire (P99-193-1410)
K262722 · HTY
Paragon 28, Inc.
Orthopedic · 28d
Cleared Aug 06, 2026
Megalodon Dynamic Compression System
K261121 · JDR
Paragon 28, Inc.
Orthopedic · 125d
Cleared Aug 03, 2026
Grappler Suture Anchor System
K262047 · MBI
Paragon 28, Inc.
Orthopedic · 46d
Cleared Mar 17, 2026
Grappler Suture Anchor PCFD Tether System
K253886 · MBI
Paragon 28, Inc.
Orthopedic · 103d
Cleared Mar 05, 2026
Phantom® Hindfoot TTC/TC Nail System
K253591 · HSB
Paragon 28, Inc.
Orthopedic · 108d
Cleared Feb 26, 2026
ENOS Software Guided External Fixation System
K253764 · OSN
Disior, Ltd.
Orthopedic · 93d
Cleared Dec 19, 2025
Monkey Rings External Ring Fixation System
K253613 · KTT
Paragon 28, Inc.
Orthopedic · 31d
Cleared Sep 30, 2025
External Fixation Mini Rail System
K252106 · KTT
Paragon 28, Inc.
Orthopedic · 89d
Cleared Sep 29, 2025
SMART PCFD
K250023 · QIH
Disior, Ltd.
Radiology · 269d
Cleared Aug 11, 2025
External Fixation Bone Distractor
K251862 · KTT
Paragon 28, Inc.
Orthopedic · 55d
Cleared Jul 18, 2025
Baby Gorilla®/Gorilla® Plating System
K250952 · HRS
Paragon 28, Inc.
Orthopedic · 112d
Cleared Jul 14, 2025
Phantom® Hindfoot TTC/TC Nail System
K251850 · HSB
Paragon 28, Inc.
Orthopedic · 28d
Cleared May 01, 2025
APEX 3D Total Ankle Replacement System
K250641 · HSN
Paragon 28, Inc.
Orthopedic · 58d
Cleared Nov 01, 2024
Monkey Bars Pin to Bar External Fixation System
K242452 · KTT
Paragon 28, Inc.
Orthopedic · 74d
Cleared Aug 22, 2024
Phantom Fibula Nail System
K234128 · HSB
Paragon 28, Inc.
Orthopedic · 238d
Cleared Jul 25, 2024
Grappler Interference Screw System
K241864 · MBI
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 02, 2024
SMART Bun-Yo-Matic X-Ray
K240736 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 24, 2024
APEX 3D Total Ankle Replacement System
K240259 · HSN
Paragon 28, Inc.
Orthopedic · 145d
Cleared Jun 20, 2024
SMART Bun-Yo-Matic CT
K240642 · QIH
Disior, Ltd.
Radiology · 106d
Cleared Jun 05, 2024
Baby Gorilla/Gorilla Plating System
K241262 · HRS
Paragon 28, Inc.
Orthopedic · 30d
Cleared Mar 26, 2024
Grappler Suture Anchor R3FLEX IOL System
K240594 · MBI
Paragon 28, Inc.
Orthopedic · 22d
Cleared Oct 12, 2023
Monkey RingsTM External Fixation System
K232838 · KTT
Paragon 28, Inc.
Orthopedic · 28d
Cleared Oct 12, 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic...
K231231 · HWC
Paragon 28, Inc.
Orthopedic · 167d