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

Filters: MBI ×
607 results
49–72 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 28, 2025
Arthrex FiberTak Suture Anchor
K250596 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 20, 2025
RootMend MRR
K243988 · MBI
Riverpoint Medical, LLC
Orthopedic · 84d
Cleared Mar 11, 2025
Arthrex TightRope Soft Button, RT
K250424 · MBI
Arthrex, Inc.
Orthopedic · 25d
Cleared Feb 25, 2025
WasherCap™ Fixation System
K250238 · MBI
Abanza Tecnomed S.L
Orthopedic · 29d
Cleared Feb 19, 2025
SuperBall-RC™
K244015 · MBI
Arcuro Medical , Ltd.
Orthopedic · 55d
Cleared Jan 31, 2025
Crius PEEK Suture Anchor System (Thread-Fix Anchor)
K243665 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 65d
Cleared Jan 30, 2025
WasherCap™ Mini Fixation System (Model 45)
K243712 · MBI
Abanza Tecnomed S.L
Orthopedic · 59d
Cleared Jan 30, 2025
Osprey Suture Anchor
K243726 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 58d
Cleared Jan 28, 2025
Argo Knotless GENESYS Anchor
K244025 · MBI
Conmed Corporation
Orthopedic · 32d
Cleared Jan 23, 2025
OTS 25-L (100-5)
K241234 · MBI
Ots Medical , Ltd.
Orthopedic · 266d
Cleared Dec 20, 2024
Tigon Medical All-Suture Anchors (ASA)
K242529 · MBI
Tigon Medical
Orthopedic · 116d
Cleared Dec 03, 2024
Fix2Lock (PEEK Self Punching)
K243470 · MBI
Osteonic Co., Ltd.
Orthopedic · 25d
Cleared Nov 26, 2024
OsseoFit Interfacing Anchor
K242494 · MBI
Riverpoint Medical, LLC
Orthopedic · 96d
Cleared Nov 19, 2024
Iconix Knotless Anchor
K243323 · MBI
Riverpoint Medical
Orthopedic · 27d
Cleared Oct 29, 2024
OC JuggerKnotless Soft Anchor
K243203 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Sep 12, 2024
Extremity All Suture System
K241695 · MBI
Field Orthopaedics
Orthopedic · 92d
Cleared Aug 29, 2024
VersaTap™ Suture Anchor (ADP050)
K242296 · MBI
Ortho-Design (Pty), Ltd.
Orthopedic · 27d
Cleared Aug 02, 2024
Fixone Meniscal Repair
K233601 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 267d
Cleared Jul 25, 2024
Grappler Interference Screw System
K241864 · MBI
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 19, 2024
Suture Button Repair System
K240835 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 115d
Cleared Jul 03, 2024
Iconix® Anchor
K241577 · MBI
Riverpoint Medical
Orthopedic · 30d
Cleared Jun 20, 2024
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue
K241435 · MBI
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 29, 2024
Arthrex TightRope II
K241235 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared May 03, 2024
Megaloop Button System
K232941 · MBI
Suzhou Endophix Co., Ltd.
Orthopedic · 226d