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"
49–72 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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 Feb 10, 2023
RENASYS™-WF White Foam NPWT Dressing Small
K213853 · OMP
Smith and Nephew Medical Limited
General & Plastic Surgery · 427d
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 22, 2022
Renasys Edge (66803126)
K223041 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 54d
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 27, 2022
CUSTMBITE Snoring System
K221322 · LRK
Dental Choice Holdings, LLC
Dental · 174d
Cleared Oct 20, 2022
SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447),...
K221740 · GCJ
Smith and Nephew, Inc.
General & Plastic Surgery · 127d
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 Sep 06, 2022
Smith+Nephew INTELLIO Tablet
K221929 · ODA
Smith & Nephew
General & Plastic Surgery · 67d
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 Jun 02, 2022
Hemosure Accu-Reader A100
K200754 · OOX
W.H.P.M., Inc.
Hematology · 801d
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 Mar 10, 2022
Smile-100 System
K212965 · LHQ
Niramai Health Analytix Private Limited
Radiology · 175d
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 Jan 14, 2022
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film...
K202783 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 479d