FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
601 results
193–216 of 601
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 28, 2019
HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
K191483 · MBI
Medos International SARL
Orthopedic · 24d
Cleared Jun 04, 2019
MectaScrew PEEK Interference Screw
K190892 · MBI
Medacta International S.A.
Orthopedic · 60d
Cleared May 28, 2019
MectaLock PEEK Suture Anchor
K190474 · MBI
Medacta International S.A.
Orthopedic · 90d
Cleared May 19, 2019
FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire,...
K190125 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 111d
Cleared Apr 24, 2019
Parcus ATLAS
K190375 · MBI
Parcus Medical, LLC
Orthopedic · 64d
Cleared Apr 17, 2019
Arthrex SwiveLock Anchors
K190728 · MBI
Arthrex, Inc.
Orthopedic · 27d