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."
49–72 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Sep 16, 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · HSX
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Aug 17, 2021
Journey II Mid-Level Tibial Inserts
K211671 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jul 29, 2021
SMART Taylor Spatial Frame
K210953 · KTT
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Jul 22, 2021
POLARSTEM Cemented Femoral Stem
K203175 · LZO
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Jul 19, 2021
POLARSTEM Calcar Reamer Guide
K211548 · LZO
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jun 29, 2021
Smith & Nephew Plates and Screws
K210837 · HRS
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared May 24, 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · MBH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 02, 2021
Extended HA Half Pins
K210784 · JDW
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Mar 25, 2021
LEGION Porous CR Narrow Femoral Components
K210566 · MBH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405 · HRS
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Nov 16, 2020
Circular Fixation with Balanced Cable Transport
K202762 · KTT
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918 · HRS
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Oct 06, 2020
R3 HA Coated Acetabular Shells
K201701 · MBL
Smith & Nephew, Inc.
Orthopedic · 106d
Cleared Jul 22, 2020
EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)
K201527 · HRS
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared Jun 04, 2020
Journey II XR Knee Instrument
K200227 · JWH
Smith & Nephew, Inc.
Orthopedic · 126d
Cleared Apr 24, 2020
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
K200826 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Mar 18, 2020
HEALICOIL Knotless Suture Anchors
K193558 · MAI
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Mar 13, 2020
LEGION Inserts with JRNY Lock
K200407 · JWH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Feb 28, 2020
CONQUEST FN
K193029 · JDO
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002 · LPH
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 25, 2019
REDAPT Blade Augments
K190847 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Sep 04, 2019
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · HRX
Smith & Nephew, Inc.
General & Plastic Surgery · 26d
Cleared Jul 25, 2019
JOURNEY II Unicompartmental Knee System
K191211 · HSX
Smith & Nephew, Inc.
Orthopedic · 80d