FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,136 results for "smith"
145–168 of 1,136
Search insights Median review: 86d Cleared: 100% Top manufacturer: Smith & Nephew, Inc. Lead specialty: Orthopedic
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
Cleared Jun 14, 2018
Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil...
K172800 · MIA
Smiths Medical Asd, Inc.
Anesthesiology · 269d
Cleared Jun 12, 2018
Portex NRFit Epidural Needles
K172823 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 267d
Cleared Jun 01, 2018
NEOSHIELD
K172499 · ONB
JMS North America Corporation
General Hospital · 287d
Cleared Jun 01, 2018
Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss...
K172410 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 296d
Cleared May 30, 2018
MICRORAPTOR REGENESORB Suture Anchor
K180361 · MAI
Smith and Nephew, Inc.
Orthopedic · 110d
Cleared May 24, 2018
Celling Aspiration Needle
K180807 · KNW
Spine Smith Holdings, LLC
Gastroenterology & Urology · 57d
Cleared May 17, 2018
CADD Yellow High Volume Administration Set with NRFit connector
K172592 · PWH
Smiths Medical Asd, Inc.
General Hospital · 261d
Cleared May 14, 2018
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
K173279 · FMI
Myco Medical Supplies, Inc.
General Hospital · 213d
Cleared May 08, 2018
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc...
K173912 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 137d
Cleared May 04, 2018
Trackit T4 EEG Amplifier
K172271 · GWQ
Lifelines , Ltd.
Neurology · 280d
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · OLO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Apr 20, 2018
PICO Single Use Negative Pressure Wound Therapy System
K180618 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 42d
Cleared Apr 10, 2018
BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect,...
K173384 · BTO
Smiths Medical Ads, Inc.
Anesthesiology · 162d
Cleared Apr 06, 2018
PICO Single Use Negative Pressure Wound Therapy System
K180614 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 29d
Cleared Mar 05, 2018
LEGION Knee System
K180334 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 02, 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 214d
Cleared Jan 25, 2018
EchoGlo Needle
K171968 · BSP
Smiths Medical Asd, Inc.
Anesthesiology · 209d
Cleared Jan 18, 2018
Lumilisse IPL Hair Remover
K172791 · OHT
Conair Corporation
General & Plastic Surgery · 125d
Cleared Jan 11, 2018
Bruxor
K172452 · OBR
Sleep Specialties, LLC
Dental · 150d
Cleared Jan 10, 2018
Smith & Nephew Patient Matched Cutting Blocks
K172336 · JWH
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Jan 08, 2018
EVOS Small Fragment Upper Extremity Plates
K173293 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 22, 2017
CONQUEST FN
K172785 · JDO
Smith & Nephew
Orthopedic · 98d