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
145–168 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 29, 2022
S-Core Implant System
K220901 · MBI
Subchondral Solutions, Inc.
Orthopedic · 123d
Cleared Jul 26, 2022
Parcus Synd-EZ SS
K221502 · MBI
Parcus Medical, LLC
Orthopedic · 64d
Cleared Jul 11, 2022
Mitek TIGHT-N Anchor
K221364 · MBI
Medos International SARL
Orthopedic · 61d
Cleared Jun 08, 2022
FairFix AM Adjustable Button FairFix PSP Adjustable Button
K221389 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared May 19, 2022
X-Twist PEEK Suture Anchor
K221135 · MBI
Parcus Medical, LLC
Orthopedic · 30d
Cleared May 13, 2022
Argo Knotless SP Anchor
K220757 · MBI
Conmed Corporation
Orthopedic · 59d
Cleared Apr 15, 2022
FootHold System
K220797 · MBI
Crossroads Extremity Systems, LLC
Orthopedic · 28d
Cleared Dec 06, 2021
VersaTap, VersaLat, DueLock, VersaTi, MiniTi
K212381 · MBI
Ortho-Design (Pty), Ltd.
Orthopedic · 126d
Cleared Oct 06, 2021
ActiFlip
K212739 · MBI
Parcus Medical, LLC
Orthopedic · 37d
Cleared Aug 30, 2021
Paratrooper Plantar Plate Repair System
K211322 · MBI
Paragon 28, Inc.
Orthopedic · 122d
Cleared Aug 04, 2021
Tigon Medical Button System
K211049 · MBI
Tigon Medical
Orthopedic · 118d
Cleared Aug 04, 2021
Alpha Vent PEEK Suture Anchor
K211502 · MBI
Stryker Endoscopy
Orthopedic · 82d
Cleared Jul 07, 2021
Grappler Suture Anchor System
K211002 · MBI
Paragon 28, Inc.
Orthopedic · 96d
Cleared Jun 07, 2021
Suture Wing
K202663 · MBI
Osteonic Co., Ltd.
Orthopedic · 266d
Cleared Jun 04, 2021
Fix2Lock (PEEK Self Punching)
K202763 · MBI
Osteonic Co., Ltd.
Orthopedic · 256d
Cleared Apr 27, 2021
Responsive Arthroscopy Thunderbolt System
K203121 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 193d
Cleared Mar 26, 2021
FairFix Adjustable Button System
K203259 · MBI
Medacta International S.A.
Orthopedic · 141d
Cleared Mar 24, 2021
Betta Link Knotless Implant System
K210498 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 30d
Cleared Mar 11, 2021
Stryker ProCinch Adjustable Loop Device
K210078 · MBI
Stryker Endoscopy
Orthopedic · 58d
Cleared Feb 22, 2021
Parcus Titanium Interference Screws
K202662 · MBI
Parcus Medical, LLC
Orthopedic · 161d
Cleared Feb 12, 2021
JuggerKnot Soft Anchor
K203740 · MBI
Riverpoint Medical
Orthopedic · 52d
Cleared Feb 11, 2021
TenoTac Soft Tissue Fixation System
K203385 · MBI
Paragon 28, Inc.
Orthopedic · 85d
Cleared Feb 01, 2021
HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
K203794 · MBI
Medos International SARL
Orthopedic · 35d
Cleared Jan 19, 2021
SnugFit All-Suture Anchor
K203485 · MBI
Medacta International S.A.
Orthopedic · 53d