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"
73–96 of 1,107
Search insights Median review: 85d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
Cleared Jan 05, 2022
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use...
K211318 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 250d
Cleared Dec 14, 2021
PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use...
K203716 · QFC
Smith and Nephew Medical Limited
General & Plastic Surgery · 358d
Cleared Dec 02, 2021
OxyLight 2.0
K202175 · GEX
Raja Trading Company, Inc.
General & Plastic Surgery · 485d
Cleared Nov 26, 2021
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length...
K210833 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 252d
Cleared Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
K211221 · MBH
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Sep 29, 2021
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit...
K203668 · BSP
Myco Medical Supplies, Inc.
Anesthesiology · 287d
Cleared Sep 16, 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · HSX
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Aug 26, 2021
Hypodermic Needle-Pro EDGE Safety Device
K211634 · FMI
Smiths Medical Asd, Inc.
General Hospital · 91d
Cleared Aug 17, 2021
Journey II Mid-Level Tibial Inserts
K211671 · JWH
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jul 29, 2021
SMART Taylor Spatial Frame
K210953 · KTT
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Jul 22, 2021
POLARSTEM Cemented Femoral Stem
K203175 · LZO
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Jul 19, 2021
POLARSTEM Calcar Reamer Guide
K211548 · LZO
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Jun 29, 2021
Smith & Nephew Plates and Screws
K210837 · HRS
Smith & Nephew, Inc.
Orthopedic · 99d
Cleared May 24, 2021
LEGION CR Porous Plus HA Femoral Components
K211246 · MBH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared May 13, 2021
Tablet Application
K203566 · ODA
Smith & Nephew
General & Plastic Surgery · 157d
Cleared Apr 02, 2021
Extended HA Half Pins
K210784 · JDW
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Mar 25, 2021
LEGION Porous CR Narrow Femoral Components
K210566 · MBH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 01, 2021
FAST-FIX FLEX
K203393 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 75d
Cleared Jan 27, 2021
EVOS Large Fragment Plating System
K203405 · HRS
Smith & Nephew, Inc.
Orthopedic · 69d
Cleared Dec 08, 2020
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator,...
K201253 · KTT
Smith & Nephew
Orthopedic · 211d
Cleared Nov 16, 2020
Circular Fixation with Balanced Cable Transport
K202762 · KTT
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918 · HRS
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Oct 30, 2020
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use...
K202157 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 88d
Cleared Oct 30, 2020
T-Lite
K201988 · IYN
Sonoscanner
Radiology · 105d