FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,107 results for "smith"
1–24 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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 May 27, 2026
RENASYS EDGE (66803126)
K260646 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 89d
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 Sep 30, 2025
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m
K251669 · DSA
Shanghai Draeger Medical Instrument...
Cardiovascular · 123d
Cleared Sep 11, 2025
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
K251826 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 90d
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 Feb 19, 2025
EVOS Pelvic and Acetabular System
K241666 · HRS
Smith & Nephew
Orthopedic · 254d
Cleared Feb 18, 2025
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port
K243576 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 91d
Cleared Feb 10, 2025
Myolight Microcurrent Handpiece
K243063 · NFO
Raja Trading Company, Inc.
Neurology · 136d
Cleared Dec 17, 2024
BIOBRANE Temporary Wound Dressing
K242146 · KGN
Smith & Nephew Medical Limited
General & Plastic Surgery · 147d
Cleared Dec 09, 2024
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · HSB
Smith & Nephew, Inc.
Orthopedic · 41d
Cleared Nov 26, 2024
REGENETEN™ Bioinductive Implant
K242631 · OWY
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 84d
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 Sep 03, 2024
EVOS Patella Plates
K240487 · HRS
Smith & Nephew
Orthopedic · 196d