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
217–240 of 607
Search insights Median review: 80d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Mar 27, 2019
Responsive Arthroscopy Wedge Push-In Suture Anchors
K190446 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 30d
Cleared Mar 18, 2019
Paradigm All-Suture Anchor 1.8mm, White/Black #2
K190333 · MBI
Conmed Corporation
Orthopedic · 32d
Cleared Mar 01, 2019
Tenodesis Screw System
K183690 · MBI
Paragon 28, Inc.
Orthopedic · 60d
Cleared Feb 26, 2019
HEALIX ADVANCE SP PEEK Anchor
K182941 · MBI
Medos International SARL
Orthopedic · 126d
Cleared Feb 21, 2019
HEALIX Ti ANCHOR with DYNACORD
K183279 · MBI
Medos International SARL
Orthopedic · 90d
Cleared Feb 07, 2019
Parcus GFS BTB
K183331 · MBI
Parcus Medical, LLC
Orthopedic · 66d
Cleared Jan 21, 2019
Tigon Medical Tissue Anchors
K182507 · MBI
Tigon Medical
Orthopedic · 131d
Cleared Jan 18, 2019
Responsive Arthroscopy Wedge Push-In Suture Anchors
K181076 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 269d
Cleared Jan 14, 2019
TenoTac Soft Tissue Fixation System
K182898 · MBI
Paragon 28, Inc.
Orthopedic · 90d
Cleared Jan 09, 2019
Cortical Fixation Systems
K181086 · MBI
Cousin Biotech Sas
Orthopedic · 259d
Cleared Jan 08, 2019
TruShot with Y-Knot Shallow All-Suture Anchor
K182439 · MBI
Conmed Corporation
Orthopedic · 123d
Cleared Jan 04, 2019
CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
K182621 · MBI
Conmed Corporation
Orthopedic · 102d
Cleared Jan 03, 2019
Responsive Arthroscopy Suture Anchor System
K180951 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 267d
Cleared Dec 28, 2018
OIC Suture Anchor System
K182736 · MBI
The Orthopaedic Implant Company
Orthopedic · 91d
Cleared Dec 21, 2018
2.8 mm/3.3 mm PopLok Suture Anchors
K181120 · MBI
Conmed Corporation
Orthopedic · 238d
Cleared Dec 19, 2018
TruShot with Y-Knot All-Suture Anchor
K182446 · MBI
Conmed Corporation
Orthopedic · 103d
Cleared Oct 19, 2018
ICONN Revolution Knotless Suture Anchor
K182264 · MBI
Iconn Orthopedics, LLC
Orthopedic · 59d
Cleared Sep 21, 2018
Arthrex FiberTak Suture Anchor
K181769 · MBI
Arthrex, Inc.
Orthopedic · 80d