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
1–24 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Oct 27, 2026
Arthrex FiberButton
K263477 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Oct 23, 2026
Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue
K263348 · MBI
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Oct 21, 2026
TeKBrace Knotless Anchor
K263352 · MBI
Theramicro
Orthopedic · 28d
Cleared Sep 17, 2026
Integrity Retractable Implant Inserter (6000127)
K261869 · MBI
Anika Therapeutics, Inc.
Orthopedic · 105d
Cleared Sep 02, 2026
Aevumed SUPERCYNCH™ Button System
K253065 · MBI
Aevumed, Inc.
Orthopedic · 345d
Cleared Sep 02, 2026
ArthroTAK Tendon Anchor Kit
K262809 · MBI
ArthroTAK, LLC
Orthopedic · 26d
Cleared Aug 27, 2026
Iconix Knotless T
K262677 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Aug 03, 2026
Grappler Suture Anchor System
K262047 · MBI
Paragon 28, Inc.
Orthopedic · 46d
Cleared Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · MBI
Stryker Endoscopy
Orthopedic · 20d
Cleared Jul 29, 2026
Suture Button Repair System
K261770 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 61d
Cleared Jul 20, 2026
Thunderbolt System
K261632 · MBI
Responsive Arthroscopy, Inc.
Orthopedic · 63d
Cleared Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue...
K261968 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 26, 2026
Arthrex FiberButton
K260018 · MBI
Arthrex, Inc.
Orthopedic · 172d
Cleared May 27, 2026
Dione PEEK Screw System
K253130 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 244d
Cleared May 13, 2026
Y-Knotless™ Flex Anchors
K261363 · MBI
Conmed Corporation
Orthopedic · 16d
Cleared May 06, 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · MBI
Ortobio S.A.
Orthopedic · 229d
Cleared May 01, 2026
ArthroTAK Tendon Anchor Kit
K252635 · MBI
ArthroTAK, LLC
Orthopedic · 254d
Cleared Apr 21, 2026
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
K260921 · MBI
Tigon Medical
Orthopedic · 33d
Cleared Mar 20, 2026
Arthrex FiberTak Suture Anchor
K260561 · MBI
Arthrex, Inc.
Orthopedic · 29d
Cleared Mar 17, 2026
Grappler Suture Anchor PCFD Tether System
K253886 · MBI
Paragon 28, Inc.
Orthopedic · 103d
Cleared Mar 16, 2026
SINEFIX
K254176 · MBI
BAAT Medical Products B.V.
Orthopedic · 83d
Cleared Mar 12, 2026
Trax EX Anchor
K251750 · MBI
Trax Surgical, Inc.
Orthopedic · 276d
Cleared Mar 11, 2026
Strut Suture
K253693 · MBI
Riverpoint Medical, LLC
Orthopedic · 110d
Cleared Mar 09, 2026
FiberTape Button
K260405 · MBI
Arthrex, Inc.
Orthopedic · 28d