FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
599 results
1–24 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
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