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

357 results for "Arthrex, Inc."
121–144 of 357
Search insights Median review: 90d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jan 15, 2020
Arthrex SwiveLock Suture Anchor
K193503 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Jan 10, 2020
Univers Revers Modular Glenoid System (Augemented baseplates)
K193372 · PHX
Arthrex, Inc.
Orthopedic · 36d
Cleared Dec 23, 2019
Arthrex Univers Revers Modular Glenoid System
K191960 · PHX
Arthrex, Inc.
Orthopedic · 153d
Cleared Dec 12, 2019
Arthrex 3.9mm Corkscrew Suture Anchor
K193157 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Nov 26, 2019
FiberTak Button
K191426 · MBI
Arthrex, Inc.
Orthopedic · 181d
Cleared Nov 06, 2019
Arthrex Nano SwiveLock Suture Anchor
K191651 · HWC
Arthrex, Inc.
Orthopedic · 139d
Cleared Oct 30, 2019
Arthrex Low Profile Screws
K190921 · HWC
Arthrex, Inc.
Orthopedic · 204d
Cleared Oct 19, 2019
Arthrex SwiveLock Anchor
K192532 · MAI
Arthrex, Inc.
Orthopedic · 33d
Cleared Oct 17, 2019
Arthrex SwiveLock Anchors
K192441 · MAI
Arthrex, Inc.
Orthopedic · 41d
Cleared Oct 16, 2019
Arthrex Minimally Invasive Ankle Fusion Plate
K190953 · HRS
Arthrex, Inc.
Orthopedic · 188d
Cleared Oct 15, 2019
Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module
K191326 · HRS
Arthrex, Inc.
Orthopedic · 152d
Cleared Oct 03, 2019
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
K191344 · HRS
Arthrex, Inc.
Orthopedic · 136d
Cleared Sep 13, 2019
Arthrex Tenodesis Button
K190288 · MBI
Arthrex, Inc.
Orthopedic · 214d
Cleared CT Jul 26, 2019
Arthrex Eclipse Shoulder Prosthesis System
K183194 · QHQ
Arthrex, Inc.
Orthopedic · 249d
Cleared Jul 05, 2019
Arthrex NanoScope System
K190645 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 114d
Cleared Jun 11, 2019
Arthrex SwiveLock Suture Anchor
K191226 · MAI
Arthrex, Inc.
Orthopedic · 35d
Cleared May 03, 2019
Arthrex DynaNite® PIP (Hammertoe) Implant
K190287 · HTY
Arthrex, Inc.
Orthopedic · 81d
Cleared Apr 17, 2019
Arthrex SwiveLock Anchors
K190728 · MBI
Arthrex, Inc.
Orthopedic · 27d
Cleared Apr 17, 2019
Arthrex 2.5 mm Tenodesis Screw
K183395 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Mar 26, 2019
Arthrex TensionLoc System
K183628 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 08, 2019
Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads
K182799 · KWS
Arthrex, Inc.
Orthopedic · 157d
Cleared Dec 21, 2018
Arthrex Fracture Adapter Hemi Shoulder Prosthesis
K181555 · KWS
Arthrex, Inc.
Orthopedic · 191d
Cleared Dec 18, 2018
Arthrex Compression FT Screws
K182361 · HWC
Arthrex, Inc.
Orthopedic · 110d
Cleared Dec 14, 2018
Arthrex SwiveLock Anchors
K180768 · MAI
Arthrex, Inc.
Orthopedic · 266d