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."
193–216 of 357
Search insights Median review: 90d Cleared: 100% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Nov 25, 2014
Univers Rivers Shoulder Prosthesis System
K142863 · PHX
Arthrex, Inc.
Orthopedic · 55d
Cleared Nov 19, 2014
Arthrex iBalance Patella Implant, Dome
K143047 · JWH
Arthrex, Inc.
Orthopedic · 27d
Cleared Sep 03, 2014
ARTHREX IBALANCE TKA SYSTEM
K141635 · MBH
Arthrex, Inc.
Orthopedic · 76d
Cleared Aug 15, 2014
ARTHREX ANKLE FUSION PLATING SYSTEM
K141735 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Aug 13, 2014
ARTHREX FIBERTAK SUTURE ANCHOR
K140476 · MBI
Arthrex, Inc.
Orthopedic · 168d
Cleared Jul 18, 2014
ARTHREX PIP DART
K141577 · HTY
Arthrex, Inc.
Orthopedic · 35d
Cleared Jul 08, 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · HRS
Arthrex, Inc.
Orthopedic · 34d
Cleared Mar 10, 2014
CMC MINI TIGHTROPE
K140328 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Feb 27, 2014
ARTHREX IBALANCE TKA SYSTEM
K133854 · JWH
Arthrex, Inc.
Orthopedic · 70d
Cleared Jan 30, 2014
ARTHREX BIOSUTURE
K140019 · GAT
Arthrex, Inc.
General & Plastic Surgery · 27d
Cleared Jan 30, 2014
MINI TIGHTROPE
K133275 · HTN
Arthrex, Inc.
Orthopedic · 98d
Cleared Dec 17, 2013
ARTHREX IBALANCE TKA SYSTEM
K133342 · JWH
Arthrex, Inc.
Orthopedic · 48d
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Oct 30, 2013
ARTHREX UNIVERS II CA HEADS
K130675 · HSD
Arthrex, Inc.
Orthopedic · 231d
Cleared Sep 27, 2013
ARTHREX UNIVERS APEX
K131633 · KWS
Arthrex, Inc.
Orthopedic · 115d
Cleared Sep 25, 2013
ARTHREX COMPRESSION PLATES
K130510 · HRS
Arthrex, Inc.
Orthopedic · 210d
Cleared Jul 31, 2013
ARTHREX SPEEDCINCH
K132043 · GAT
Arthrex, Inc.
General & Plastic Surgery · 29d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · HRS
Arthrex, Inc.
Orthopedic · 42d
Cleared May 31, 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · KWS
Arthrex, Inc.
Orthopedic · 134d
Cleared May 03, 2013
KNOTLESS FIBERTAK SUTURE ANCHOR
K130458 · MBI
Arthrex, Inc.
Orthopedic · 70d
Cleared Apr 05, 2013
ARTHREX FRACTURE PLATES
K123241 · HRS
Arthrex, Inc.
Orthopedic · 170d
Cleared Dec 21, 2012
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON,...
K123341 · MBI
Arthrex, Inc.
Orthopedic · 51d
Cleared Sep 25, 2012
ARTHREX SUTURE (UHMWPE)
K122374 · GAT
Arthrex, Inc.
General & Plastic Surgery · 50d
Cleared May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · FMF
Arthrex, Inc.
General Hospital · 33d