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
169–192 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 08, 2021
Button Loop
K202291 · MBI
Yunyi (Beijing) Medical Device Co., Ltd.
Orthopedic · 149d
Cleared Dec 15, 2020
Fixone All Suture Anchor
K192709 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 445d
Cleared Nov 27, 2020
Arthrex FiberTak Suture Anchor
K203268 · MBI
Arthrex, Inc.
Orthopedic · 22d
Cleared Nov 25, 2020
TopLock Anchor System
K193377 · MBI
Fusion Orthopedics, LLC
Orthopedic · 356d
Cleared Nov 25, 2020
Sterile bone screw (PEEK ACL screw)
K202883 · MBI
Osteonic Co., Ltd.
Orthopedic · 58d
Cleared Nov 17, 2020
Knotless TensionTight Button Implant System
K202444 · MBI
Arthrex, Inc.
Orthopedic · 83d
Cleared Nov 13, 2020
VersaLoop Anchor System
K202178 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 101d
Cleared Nov 13, 2020
Stryker Omega PEEK Knotless Anchor System
K202355 · MBI
Stryker
Orthopedic · 86d
Cleared Nov 10, 2020
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw...
K193214 · MBI
Biomet, Inc.
Orthopedic · 355d
Cleared Nov 10, 2020
Multi-Drive Interference Screw System
K200428 · MBI
Nvision Biomedical Technologies, Inc.
Orthopedic · 263d
Cleared Nov 04, 2020
Arthrex TightRope II
K202581 · MBI
Arthrex, Inc.
Orthopedic · 57d
Cleared Oct 28, 2020
Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ...
K202259 · MBI
Parcus Medical, LLC
Orthopedic · 79d
Cleared Oct 16, 2020
PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP...
K202193 · MBI
S.B.M. Sas (Science & Bio Materials)
Orthopedic · 72d
Cleared Oct 07, 2020
Flower Suture Anchor Set
K192949 · MBI
Flower Orthopedics Corporation
Orthopedic · 355d
Cleared Sep 18, 2020
OrthoButton FL
K202399 · MBI
Riverpoint Medical
Orthopedic · 28d
Cleared Sep 09, 2020
Responsive Arthroscopy Suture Anchor System
K202153 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 37d
Cleared Sep 02, 2020
ATL Anchors
K200503 · MBI
International Life Sciences
Orthopedic · 184d
Cleared Aug 20, 2020
Hercules Suture Anchor System
K201636 · MBI
In2bones USA, LLC
Orthopedic · 65d
Cleared Aug 07, 2020
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite...
K201883 · MBI
Medos International SARL
Orthopedic · 30d
Cleared Jul 23, 2020
Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors
K201083 · MBI
Parcus Medical, LLC
Orthopedic · 91d
Cleared Jun 04, 2020
HEALIX ADVANCE Anchor with DYNATAPE Suture
K200949 · MBI
Medos International SARL
Orthopedic · 56d
Cleared Mar 26, 2020
Bonecam Suture Anchor
K193108 · MBI
Valeris Medical, Inc.
Orthopedic · 139d
Cleared Mar 12, 2020
Arthrex FiberTak Suture Anchor
K200341 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Mar 11, 2020
Apollo Suture Anchor System
K192810 · MBI
Valeris Medical
Orthopedic · 162d