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
25–48 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 06, 2026
TeKBrace Knotless Anchor
K253538 · MBI
Theramicro
Orthopedic · 113d
Cleared Mar 04, 2026
Aevumed FENIX Suture Anchor
K254306 · MBI
Aevumed, Inc.
Orthopedic · 63d
Cleared Mar 02, 2026
Arthrex Nano FiberTak Suture Anchor
K254229 · MBI
Arthrex, Inc.
Orthopedic · 63d
Cleared Feb 27, 2026
LigaMend
K253695 · MBI
Riverpoint Medical, LLC
Orthopedic · 98d
Cleared Jan 29, 2026
Y-Knotless™ Flex Anchors
K253763 · MBI
Conmed Corporation
Orthopedic · 65d
Cleared Jan 28, 2026
Aevumed PROTEKT Suture Anchor
K260004 · MBI
Aevumed, Inc.
Orthopedic · 26d
Cleared Jan 06, 2026
QuadLock™ Fixation System
K253618 · MBI
Abanza Tecnomed S.L
Orthopedic · 49d
Cleared Dec 30, 2025
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · MBI
Arthrex, Inc.
Orthopedic · 26d
Cleared Dec 04, 2025
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · MBI
Tigon Medical
Orthopedic · 111d
Cleared Nov 04, 2025
GMReis Suture Anchors
K252664 · MBI
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 74d
Cleared Oct 29, 2025
Arthrex SutureTak Suture Anchor
K252314 · MBI
Arthrex, Inc.
Orthopedic · 96d
Cleared Oct 21, 2025
Aevumed FASE Suture Anchor
K253040 · MBI
Aevumed, Inc.
Orthopedic · 29d
Cleared Oct 14, 2025
Mini Superhawk Suture Anchor System
K253010 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 25d
Cleared Sep 05, 2025
All-Suture Dual Anchor System
K250095 · MBI
Suturetech, Inc.
Orthopedic · 234d
Cleared Aug 06, 2025
Aevumed PHANTOM Suture Anchors
K242895 · MBI
Aevumed, Inc.
Orthopedic · 317d
Cleared Jul 30, 2025
Iconix Speed Anchor
K252144 · MBI
Riverpoint Medical
Orthopedic · 22d
Cleared Jul 22, 2025
OTS 25-L (100-5)
K251310 · MBI
Ots Medical , Ltd.
Orthopedic · 85d
Cleared Jul 18, 2025
Arthrex FiberTak Suture Anchor
K251809 · MBI
Arthrex, Inc.
Orthopedic · 36d
Cleared Jul 10, 2025
Arthrex PushLock Suture Anchors
K251145 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared Jul 01, 2025
SnugFit ASA Extension
K251933 · MBI
Medacta International S.A.
Orthopedic · 7d
Cleared Jun 25, 2025
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)
K251627 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 18, 2025
CONMED Argo Knotless® Anchor
K251530 · MBI
Conmed Corporation
Orthopedic · 30d
Cleared Jun 02, 2025
PULLUP®
K250844 · MBI
Science & Bio Materials (S.B.M.) Sas
Orthopedic · 74d
Cleared May 12, 2025
Shoulder Soft Tissue Anchors
K242477 · MBI
Signature Orthopaedics Pty, Ltd.
Orthopedic · 264d