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"
121–144 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Oct 04, 2019
Urethrotech UCD
K190060 · EZL
Urethrotech
Gastroenterology & Urology · 266d
Cleared Sep 04, 2019
Smith & Nephew DYONICS 25 Fluid Management System
K192155 · HRX
Smith & Nephew, Inc.
General & Plastic Surgery · 26d
Cleared Aug 23, 2019
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi,...
K191177 · GCJ
Smith and Nephew, Inc.
General & Plastic Surgery · 113d
Cleared Aug 23, 2019
CustMBite Dental Guard
K183315 · OBR
Dental Choice Holdings, LLC
Dental · 266d
Cleared Aug 12, 2019
Dr J Spinal and Epidural Needles
K183316 · BSP
Dr. Japan Co., Ltd.
Anesthesiology · 255d
Cleared Jul 25, 2019
JOURNEY II Unicompartmental Knee System
K191211 · HSX
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared May 21, 2019
Smith & Nephew Tablet Application
K190367 · QGY
Smith & Nephew
General & Plastic Surgery · 95d
Cleared Mar 21, 2019
RENASYS Touch
K181822 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 255d
Cleared Mar 12, 2019
Double ENDOBUTTON Fixation Device
K183232 · HTN
Smith and Nephew, Inc.
Orthopedic · 112d
Cleared Mar 11, 2019
EVOS Small Fragment Upper Extremity Plates Line Additions
K190253 · HRS
Smith & Nephew, Inc.
Orthopedic · 32d
Cleared Feb 11, 2019
Journey II Unicompartmental Knee System
K190085 · HSX
Smith & Nephew, Inc.
Orthopedic · 25d
Cleared Jan 18, 2019
PICO 7Y Single Use Negative Pressure Wound Therapy System
K182323 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 144d
Cleared Jan 16, 2019
Dosis SAM
K180410 · MQS
Dosis, Inc.
Gastroenterology & Urology · 336d
Cleared Jan 10, 2019
RENASYS Y-Connector
K181204 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 248d
Cleared Nov 28, 2018
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
K183010 · JWH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Nov 19, 2018
R3 Anteverted Liners
K182535 · MBL
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Nov 16, 2018
REDAPT Modular Acetabular Shell
K182109 · LPH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Sep 28, 2018
MICRORAPTOR Knotless Suture Anchor
K181746 · MAI
Smith and Nephew, Inc.
Orthopedic · 88d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366 · LPH
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Aug 21, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K180698 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 158d
Cleared Aug 16, 2018
IGTFusion
K180522 · LLZ
Igi Technologies
Radiology · 170d
Cleared Aug 09, 2018
EVOS Wrist Fracture Plating System
K181533 · HRS
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Jul 27, 2018
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
K180580 · KTT
Surgical Instrument Service and...
Orthopedic · 144d
Cleared Jul 26, 2018
Level 1 Convective Warmer
K181699 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 29d