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
217–240 of 599
Search insights Median review: 81d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Aug 30, 2018
Arthrex PushLock Tenodesis Anchor
K181513 · MBI
Arthrex, Inc.
Orthopedic · 83d
Cleared Aug 09, 2018
SECULOK™ Suture Anchor
K180759 · MBI
U&I Corporation
Orthopedic · 140d
Cleared Aug 09, 2018
ICONN Answer II Suture Anchor
K181680 · MBI
Iconn Orthopedics, LLC
Orthopedic · 44d
Cleared Aug 06, 2018
Arthrex SwiveLock
K173845 · MBI
Arthrex, Inc.
Orthopedic · 230d
Cleared Jul 23, 2018
Stryker All-PEEK Knotless Anchor System
K181083 · MBI
Stryker
Orthopedic · 90d
Cleared May 31, 2018
AEVUMED PHANTOM Suture Anchors
K180464 · MBI
Aevumed, Inc.
Orthopedic · 99d
Cleared May 30, 2018
KATOR Suture Anchor
K173269 · MBI
Kator, LLC
Orthopedic · 230d
Cleared Apr 04, 2018
ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
K173074 · MBI
Stryker
Orthopedic · 187d