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

549 results for "Smith & Nephew, Inc."
73–96 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · HRS
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Feb 11, 2019
Journey II Unicompartmental Knee System
K190085 · HSX
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Nov 28, 2018
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
K183010 · JWH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Nov 19, 2018
R3 Anteverted Liners
K182535 · MBL
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Nov 16, 2018
REDAPT Modular Acetabular Shell
K182109 · LPH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Aug 09, 2018
EVOS Wrist Fracture Plating System
K181533 · HRS
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · OLO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Mar 05, 2018
LEGION Knee System
K180334 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jan 10, 2018
Smith & Nephew Patient Matched Cutting Blocks
K172336 · JWH
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Jan 08, 2018
EVOS Small Fragment Upper Extremity Plates
K173293 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 30, 2017
Birmingham Hip (BH) Dual Mobility Insert
K171934 · LPH
Smith & Nephew, Inc.
Orthopedic · 155d
Cleared Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
K171073 · LPH
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Nov 16, 2017
JOURNEY II XR Knee Instruments
K173331 · JWH
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684 · LPH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 23, 2017
EVOS Small Fragment Plating System
K172262 · HRS
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jun 27, 2017
Smith & Nephew 25 Fluid Management System
K171794 · HRX
Smith & Nephew, Inc.
Orthopedic · 11d
Cleared Jun 19, 2017
Smith & Nephew, Inc. R3™ Constrained Liner
K162641 · KWZ
Smith & Nephew, Inc.
Orthopedic · 270d
Cleared Jun 14, 2017
EVOS Small Fragment Lower Extremity Plates
K170457 · HRS
Smith & Nephew, Inc.
Orthopedic · 119d
Cleared Jun 08, 2017
INVISIKNOT Ankle Syndesmosis Repair Kit
K162996 · HTN
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared May 22, 2017
Smith & Nephew VISIONAIRE Adaptive Guides
K170282 · JWH
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared May 11, 2017
ANTHEM CR Total Knee System
K170648 · JWH
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 01, 2017
REDAPT Sleeved Monolithic Revision Stems
K162303 · MEH
Smith & Nephew, Inc.
Orthopedic · 257d