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
241–264 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 30, 2018
Arthrex PushLock Tenodesis Anchor
K181513 · MBI
Arthrex, Inc.
Orthopedic · 83d
Cleared Aug 09, 2018
SECULOK™ Suture Anchor
K180759 · MBI
U&I Corporation
Orthopedic · 140d
Cleared Aug 09, 2018
ICONN Answer II Suture Anchor
K181680 · MBI
Iconn Orthopedics, LLC
Orthopedic · 44d
Cleared Aug 06, 2018
Arthrex SwiveLock
K173845 · MBI
Arthrex, Inc.
Orthopedic · 230d
Cleared Jul 23, 2018
Stryker All-PEEK Knotless Anchor System
K181083 · MBI
Stryker
Orthopedic · 90d
Cleared May 31, 2018
AEVUMED PHANTOM Suture Anchors
K180464 · MBI
Aevumed, Inc.
Orthopedic · 99d
Cleared May 30, 2018
KATOR Suture Anchor
K173269 · MBI
Kator, LLC
Orthopedic · 230d
Cleared Apr 04, 2018
ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
K173074 · MBI
Stryker
Orthopedic · 187d
Cleared Mar 21, 2018
Ventix Link Knotless Anchor with Inserter
K180274 · MBI
Cayenne Medical, Inc.
Orthopedic · 49d
Cleared Feb 12, 2018
Arthrex NanoSuture Anchor
K180118 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared Jan 05, 2018
ToggleLoc System
K173278 · MBI
Biomet, Inc.
Orthopedic · 84d
Cleared Nov 29, 2017
ICONN Square 2.5MM Suture Anchor
K172491 · MBI
Iconn Orthopedics, LLC
Orthopedic · 104d
Cleared Nov 20, 2017
Stryker Self-Punching ICONIX
K172921 · MBI
Stryker
Orthopedic · 56d
Cleared Oct 23, 2017
M-ARS ACL: Anatomic Ribbon Surgery System
K171640 · MBI
Medacta International S.A.
Orthopedic · 143d
Cleared Oct 16, 2017
BioWick X Implant with Driver
K172186 · MBI
Cayenne Medical, Inc.
Orthopedic · 88d
Cleared Sep 28, 2017
FiberTak DX
K172612 · MBI
Arthex, Inc.
Orthopedic · 28d
Cleared Sep 19, 2017
LigaMetrics Suture Anchors
K171964 · MBI
Mortise Medical, LLC
Orthopedic · 81d
Cleared Sep 08, 2017
CuffLink Implant System
K171725 · MBI
Conmed Corporation
Orthopedic · 88d
Cleared Aug 24, 2017
Stryker Self-Punching ICONIX
K171465 · MBI
Stryker
Orthopedic · 98d
Cleared Aug 17, 2017
Q-Fix Suture Anchor
K172165 · MBI
ArthroCare Corporation
Orthopedic · 30d
Cleared Jul 25, 2017
ANCHORMAN Tibial Ligament Fixation Device
K170388 · MBI
Summit Medical , Ltd.
Orthopedic · 167d
Cleared Jun 02, 2017
Parcus SLiK Fix Screw
K170877 · MBI
Parcus Medical
Orthopedic · 70d
Cleared Jun 02, 2017
OrthoButton AL
K171060 · MBI
Riverpoint Medical
Orthopedic · 53d
Cleared May 16, 2017
Arthrex Knotless SutureTak Anchor
K171020 · MBI
Arthrex, Inc.
Orthopedic · 41d