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."
1–24 of 549
Search insights Median review: 79d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 27, 2026
Tendon Anchor
K263461 · GDW
Smith & Nephew, Inc.
General & Plastic Surgery · 29d
Cleared Oct 23, 2026
Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue
K263348 · MBI
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Sep 08, 2026
LANDMARK Total Knee System
K261462 · MBH
Smith & Nephew, Inc.
Orthopedic · 127d
Cleared Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue...
K261968 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Not Cleared Jul 06, 2026
TESSA Spatial Surgery System
DEN250037 · SIQ
Smith & Nephew, Inc.
Orthopedic · 318d
Cleared Apr 06, 2026
AETOS Shoulder System - CONCELOC Glenoids
K254084 · KWS
Smith & Nephew, Inc.
Orthopedic · 109d
Cleared Oct 29, 2025
AETOS Shoulder System Meta Humeral Prosthesis Size 0
K252416 · KWS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Jun 25, 2025
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)
K251627 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 12, 2025
TRIGEN Stable Lock Nut & Washer
K243608 · JDS
Smith & Nephew, Inc.
Orthopedic · 202d
Cleared Apr 02, 2025
LEGION Total Knee System
K250677 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Mar 28, 2025
CATALYSTEM Femoral Stems
K250571 · LZO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Dec 09, 2024
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · HSB
Smith & Nephew, Inc.
Orthopedic · 41d
Cleared Nov 20, 2024
AETOS Shoulder System Stemless Humeral Prosthesis
K240716 · PKC
Smith & Nephew, Inc.
Orthopedic · 250d
Cleared Oct 30, 2024
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
K242711 · HSX
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Oct 21, 2024
Anthology Hip Stems
K240783 · JDI
Smith & Nephew, Inc.
Orthopedic · 214d
Cleared Oct 07, 2024
OR3O Dual Mobility System
K242375 · LPH
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Sep 20, 2024
TRIGEN MAX Tibial Nail System
K240061 · JDS
Smith & Nephew, Inc.
Orthopedic · 255d
Cleared Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
K241804 · JDS
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jun 27, 2024
CATALYSTEM Femoral Stems
K240381 · LZO
Smith & Nephew, Inc.
Orthopedic · 140d
Cleared Jun 20, 2024
Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue
K241435 · MBI
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 18, 2024
CORIOGRAPH Knee Pre-Op Plan
K240113 · PBF
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Mar 13, 2024
ACCORD Cable System
K233949 · JDQ
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Dec 21, 2023
Cannulated Screw System
K233396 · HWC
Smith & Nephew, Inc.
Orthopedic · 79d