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
193–216 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 05, 2020
ALLthread PEEK Suture Anchor
K193402 · MBI
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 04, 2020
Coronet Soft Tissue Fixation System
K200028 · MBI
Conextions Medical
Orthopedic · 58d
Cleared Feb 14, 2020
Dunamis PunchTac Suture Anchors
K193245 · MBI
Dunamis, LLC
Orthopedic · 81d
Cleared Feb 10, 2020
MectaFix CL Fixation Button with Continuous Loop
K193165 · MBI
Medacta International S.A.
Orthopedic · 87d
Cleared Feb 06, 2020
MectaLock All-Suture Anchors
K193461 · MBI
Medacta International S.A.
Orthopedic · 52d
Cleared Jan 29, 2020
MectaTap TI Suture Anchor
K191677 · MBI
Medacta International S.A.
Orthopedic · 219d
Cleared Jan 24, 2020
Paratrooper Plantar Plate Repair System
K191227 · MBI
Paragon 28, Inc.
Orthopedic · 262d
Cleared Jan 23, 2020
Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
K193295 · MBI
Parcus Medical, LLC
Orthopedic · 57d
Cleared Jan 22, 2020
Y-Knot OneStep Anchor
K193606 · MBI
Conmed Corporation
Orthopedic · 30d
Cleared Jan 16, 2020
AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip
K192750 · MBI
Parcus Medical, LLC
Orthopedic · 108d
Cleared Jan 16, 2020
ALLthread Titanium Suture Anchor
K192942 · MBI
Biomet, Inc.
Orthopedic · 90d
Cleared Jan 02, 2020
TunneLoc Tibial Fixation Device
K193092 · MBI
Biomet, Inc.
Orthopedic · 57d
Cleared Nov 26, 2019
FiberTak Button
K191426 · MBI
Arthrex, Inc.
Orthopedic · 181d
Cleared Nov 22, 2019
Parcus Synd-EZ SS
K192964 · MBI
Parcus Medical, LLC
Orthopedic · 30d
Cleared Oct 09, 2019
Parcus Synd-EZ Ti
K191783 · MBI
Parcus Medical, LLC
Orthopedic · 98d
Cleared Oct 05, 2019
AFX Femoral Implant with Inserter
K192428 · MBI
Cayenne Medical
Orthopedic · 30d
Cleared Sep 13, 2019
Arthrex Tenodesis Button
K190288 · MBI
Arthrex, Inc.
Orthopedic · 214d
Cleared Sep 13, 2019
JuggerStitch Meniscal Repair Device
K191459 · MBI
Biomet, Inc.
Orthopedic · 102d
Cleared Sep 12, 2019
MectaLock Ti Suture Anchor
K191300 · MBI
Medacta International S.A.
Orthopedic · 121d
Cleared Aug 29, 2019
Dunamis Fixation Button System
K191319 · MBI
Dunamis, LLC
Orthopedic · 106d
Cleared Jul 25, 2019
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
K190774 · MBI
Medos International SARL
Orthopedic · 121d
Cleared Jul 17, 2019
Xtreme-Loop
K191053 · MBI
Xiros, Ltd.
Orthopedic · 89d
Cleared Jul 03, 2019
OsteoFab Suture Anchors
K190915 · MBI
Oxford Performance Materials, Inc.
Orthopedic · 85d
Cleared Jul 03, 2019
Infinity Fixation System
K191204 · MBI
Conmed Corporation
Orthopedic · 58d