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."
25–48 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 27, 2023
OR3O Dual Mobility Liners
K232667 · LPH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Aug 09, 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles,...
K231376 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 04, 2023
HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue)
K232005 · MBI
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 19, 2023
TANDEM Hip System
K231448 · LZY
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jun 14, 2023
TRIGEN META-NAIL Nail System
K230761 · JDS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Jun 07, 2023
AETOS Shoulder System
K230572 · KWS
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared May 04, 2023
Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System,...
K230653 · JWH
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Mar 30, 2023
Cemented Tibia Baseplate no Taper with JRNY Lock
K230555 · JWH
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 17, 2023
ULTRABUTTON QUAD Adjustable Fixation Device
K222971 · MBI
Smith & Nephew, Inc.
Orthopedic · 143d
Cleared Jan 03, 2023
AETOS Shoulder System
K220847 · KWS
Smith & Nephew, Inc.
Orthopedic · 286d
Cleared Dec 08, 2022
MAVERICK Mini External Fixation System
K223112 · JDW
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Nov 14, 2022
Smith & Nephew Intramedullary Nail Systems
K210980 · HSB
Smith & Nephew, Inc.
Orthopedic · 592d
Cleared Oct 28, 2022
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
K222653 · NJD
Smith & Nephew, Inc.
Orthopedic · 57d
Cleared Oct 18, 2022
EVOS Wrist Spanning Plate
K213123 · HRS
Smith & Nephew, Inc.
Orthopedic · 386d
Cleared Sep 29, 2022
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad,...
K213126 · JDO
Smith & Nephew, Inc.
Orthopedic · 367d
Cleared Aug 25, 2022
Acute QC Strut and Components
K221792 · OSN
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Aug 18, 2022
OR3O Dual Mobility System
K220959 · LPH
Smith & Nephew, Inc.
Orthopedic · 139d
Cleared Jul 26, 2022
Cemented Round Patella with JRNY Pegs
K221939 · JWH
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Jul 01, 2022
Smith & Nephew Hip Systems
K211176 · LPH
Smith & Nephew, Inc.
Orthopedic · 437d
Cleared Apr 26, 2022
Legion Inserts with JRNY Lock
K220896 · JWH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 11, 2022
TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN...
K213827 · KWS
Smith & Nephew, Inc.
Orthopedic · 93d
Cleared Feb 11, 2022
MAVERICK External Fixation System
K213874 · JDW
Smith & Nephew, Inc.
Orthopedic · 60d
Cleared Jan 19, 2022
R3 Large Head Liners
K211330 · LPH
Smith & Nephew, Inc.
Orthopedic · 261d
Cleared Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
K211221 · MBH
Smith & Nephew, Inc.
Orthopedic · 161d