FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: MBI ×
599 results
145–168 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jan 08, 2021
Button Loop
K202291 · MBI
Yunyi (Beijing) Medical Device Co., Ltd.
Orthopedic · 149d
Cleared Dec 15, 2020
Fixone All Suture Anchor
K192709 · MBI
Aju Pharm Co., Ltd.
Orthopedic · 445d
Cleared Nov 27, 2020
Arthrex FiberTak Suture Anchor
K203268 · MBI
Arthrex, Inc.
Orthopedic · 22d
Cleared Nov 25, 2020
TopLock Anchor System
K193377 · MBI
Fusion Orthopedics, LLC
Orthopedic · 356d
Cleared Nov 25, 2020
Sterile bone screw (PEEK ACL screw)
K202883 · MBI
Osteonic Co., Ltd.
Orthopedic · 58d
Cleared Nov 17, 2020
Knotless TensionTight Button Implant System
K202444 · MBI
Arthrex, Inc.
Orthopedic · 83d
Cleared Nov 13, 2020
VersaLoop Anchor System
K202178 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 101d
Cleared Nov 13, 2020
Stryker Omega PEEK Knotless Anchor System
K202355 · MBI
Stryker
Orthopedic · 86d