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."
25–48 of 59
Search insights Median review: 85d Cleared: 100% Top manufacturer: Paragon 28, Inc. Lead specialty: Orthopedic
Cleared Aug 22, 2023
TITAN 3-D Wedge System
K231496 · PLF
Paragon 28, Inc.
Orthopedic · 90d
Cleared Aug 21, 2023
Grappler Suture Anchor System
K231867 · MBI
Paragon 28, Inc.
Orthopedic · 56d
Cleared May 11, 2023
JAWS Nitinol Staple System
K230550 · JDR
Paragon 28, Inc.
Orthopedic · 72d
Cleared Mar 03, 2023
Grappler Suture Anchor R3FLEX IOL System
K223589 · MBI
Paragon 28, Inc.
Orthopedic · 92d
Cleared Feb 16, 2023
JAWS Nitinol Staple System
K223056 · JDR
Paragon 28, Inc.
Orthopedic · 139d
Cleared Dec 16, 2022
Phantom Metatarsal Shortening System
K223184 · HWC
Paragon 28, Inc.
Orthopedic · 65d
Cleared Nov 17, 2022
MAVEN™ Patient-Specific Instrumentation
K223227 · HSN
Paragon 28, Inc.
Orthopedic · 30d
Cleared Sep 14, 2022
Grappler Suture Anchor System
K222091 · MBI
Paragon 28, Inc.
Orthopedic · 61d
Cleared Aug 19, 2022
Baby Gorilla®/Gorilla® Plating System
K222194 · HRS
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jun 28, 2022
Patient Specific Marking Guides
K211076 · PBF
Additive Orthopaedics, LLC
Orthopedic · 442d
Cleared Jun 17, 2022
Baby Gorilla/Gorilla Plating System
K221465 · HRS
Paragon 28, Inc.
Orthopedic · 29d
Cleared Dec 25, 2021
R3ACT Stabilization System
K211770 · HWC
Paragon 28, Inc.
Orthopedic · 200d
Cleared Nov 08, 2021
Paragon 28 External Ring Fixation System
K212895 · KTT
Paragon 28, Inc.
Orthopedic · 59d
Cleared Aug 30, 2021
Paratrooper Plantar Plate Repair System
K211322 · MBI
Paragon 28, Inc.
Orthopedic · 122d
Cleared Jul 07, 2021
Grappler Suture Anchor System
K211002 · MBI
Paragon 28, Inc.
Orthopedic · 96d
Cleared Jun 28, 2021
Phantom Hindfoot TTC/TC Nail System
K210869 · HSB
Paragon 28, Inc.
Orthopedic · 97d
Cleared Mar 06, 2021
Apex 3D Total Ankle Replacement System
K210390 · HSN
Paragon 28, Inc.
Orthopedic · 25d
Cleared Feb 11, 2021
TenoTac Soft Tissue Fixation System
K203385 · MBI
Paragon 28, Inc.
Orthopedic · 85d
Cleared Jan 14, 2021
Maven Patient-Specific Instrumentation
K202019 · HSN
Paragon 28, Inc.
Orthopedic · 177d
Cleared Dec 29, 2020
Baby Gorilla/Gorilla Plating System
K203511 · HRS
Paragon 28, Inc.
Orthopedic · 29d
Cleared Nov 13, 2020
Monster Screw System
K203011 · HWC
Paragon 28, Inc.
Orthopedic · 43d
Cleared Nov 13, 2020
APEX 3D Total Ankle Replacement System
K202373 · HSN
Paragon 28, Inc.
Orthopedic · 86d
Cleared Jul 17, 2020
Phantom® Hindfoot TTC/TC Nail System
K201227 · HSB
Paragon 28, Inc.
Orthopedic · 72d
Cleared Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
K192994 · HSN
Paragon 28, Inc.
Orthopedic · 259d