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
265–288 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 31, 2017
ICONIX TT All Suture Anchor
K170098 · MBI
Stryker
Orthopedic · 79d
Cleared Mar 30, 2017
Parcus SLiK Anchors
K170327 · MBI
Parcus Medical
Orthopedic · 56d
Cleared Feb 23, 2017
GRAVITYTM PEEK-OPTIMA Suture Anchor
K170265 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Jan 25, 2017
CrossFT Knotless Suture Anchor with Disposable Driver
K163258 · MBI
Conmed Corporation
Orthopedic · 65d
Cleared Dec 07, 2016
SUTUREFIX Curved Suture Anchor
K163034 · MBI
Smith and Nephew, Inc.
Orthopedic · 37d
Cleared Nov 18, 2016
GFS Ultimate
K162198 · MBI
Parcus Medical, LLC
Orthopedic · 105d
Cleared Oct 25, 2016
KATOR Suture Anchor
K162386 · MBI
Kator, LLC
Orthopedic · 61d
Cleared Aug 03, 2016
AFX™ Femoral Implant With Inserter
K161033 · MBI
Cayenne Medical, Inc.
Orthopedic · 112d
Cleared Jul 06, 2016
Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
K160996 · MBI
Dunamis, LLC
Orthopedic · 89d
Cleared Jun 09, 2016
MILAGRO ADVANCE PEEK Interference Screw
K161001 · MBI
Medos International SARL
Orthopedic · 59d
Cleared Jun 03, 2016
OrthoButton CL
K160655 · MBI
Riverpoint Medical
Orthopedic · 87d
Cleared May 10, 2016
FiberTak DR
K160319 · MBI
Arthrex, Inc.
Orthopedic · 95d
Cleared May 05, 2016
Flip Button Suture Anchor
K153585 · MBI
First Ray, LLC
Orthopedic · 141d
Cleared May 03, 2016
STROPP (Single Tunnel Repair of Plantar Plate)
K160118 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 105d
Cleared Apr 21, 2016
Ventix Suture Anchor
K153558 · MBI
Biomet Manufacturing Corp
Orthopedic · 129d
Cleared Apr 20, 2016
Elite SPK, Compasso, Elite SPK Kit
K160500 · MBI
Ncs Lab Srl
Orthopedic · 57d
Cleared Mar 24, 2016
TRUESPAN Meniscal Repair System
K153667 · MBI
Medos International SARL
Orthopedic · 94d
Cleared Mar 08, 2016
Ventix Knotless Anchors
K152262 · MBI
Biomet Manufacturing Corp
Orthopedic · 210d
Cleared Feb 23, 2016
Arthrex Short Suture Anchors
K151092 · MBI
Arthrex, Inc.
Orthopedic · 306d
Cleared Jan 28, 2016
Adjustable Fixation Device
K153186 · MBI
Arthrocare Corp.
Orthopedic · 86d
Cleared Jan 19, 2016
MultiFIX S Ultra Knotless Fixation System
K153669 · MBI
Arthocare Corporation
Orthopedic · 29d
Cleared Dec 11, 2015
SpeedLock Knotless Fixation System
K153313 · MBI
ArthroCare Corporation
Orthopedic · 24d
Cleared Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01,...
K152566 · MBI
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 20, 2015
Parcus GFS Naked
K152711 · MBI
Parcus Medical, LLC
Orthopedic · 60d