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

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175,820 results
25345–25368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2018
I-Portal Neuro Otologic Test Center
K181025 · GWN
Neuro Kinetics, Inc.
Neurology · 97d
Cleared Jul 24, 2018
RF-Relief
K181095 · PBX
El Global Trade, Ltd.
General & Plastic Surgery · 89d
Cleared Jul 24, 2018
S-mini active Fixture
K181178 · DZE
Neobiotech Co., Ltd.
Dental · 83d
Cleared Jul 24, 2018
Altus Spine Pedicle Screw System
K181339 · NKB
Altus Partners, LLC
Orthopedic · 64d
Cleared Jul 24, 2018
FIREFLY® Pedicle Screw Navigation Guide
K181399 · PQC
Mighty Oak Medical, Inc.
Orthopedic · 56d
Cleared Jul 24, 2018
CELERITY 20 Steam Biological Indicator
K181686 · FRC
STERIS Corporation
General Hospital · 28d
Cleared Jul 23, 2018
Non-contact infrared body thermometer
K171888 · FLL
Hetaida Technology Co., Ltd.
General Hospital · 392d
Cleared Jul 23, 2018
Quantitative Total Extensible Imaging (QTxI)
K173444 · LLZ
Aiq Solutions, Inc.
Radiology · 259d
Cleared Jul 23, 2018
JASPER Spinal Fixation System
K173645 · NKB
Gbs Commonwealth Co., Ltd.
Orthopedic · 238d
Cleared Jul 23, 2018
GME LinScan Lite 808 Laser System
K180518 · GEX
Gme (German Medical Engineering) GmbH
General & Plastic Surgery · 146d
Cleared Jul 23, 2018
Voyager Trajectory Array Guide (V-TAG)
K180854 · HAW
Voyager Therapeutics, Inc.
Neurology · 112d
Cleared Jul 23, 2018
Stryker All-PEEK Knotless Anchor System
K181083 · MBI
Stryker
Orthopedic · 90d
Cleared Jul 23, 2018
Braun BNT400 No Touch + Forehead Thermometer
K181242 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 74d
Cleared Jul 23, 2018
DV-300 Aspirator
K181398 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 55d
Cleared Jul 20, 2018
The Graft Natural Bone Substitute
K173188 · NPM
Purgo Biologics, Inc.
Dental · 291d
Cleared Jul 20, 2018
NicoletOne
K173366 · OLZ
Natus Neurology Incorporated
Neurology · 267d
Cleared Jul 20, 2018
AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening...
K173675 · FRO
Convatec Limited
General & Plastic Surgery · 232d
Cleared Jul 20, 2018
TV-100
K173973 · CBK
Bio-Med Devices, Inc.
Anesthesiology · 203d
Cleared Jul 20, 2018
Athena Cervical Plate System
K180022 · KWQ
Medyssey USA, Inc.
Orthopedic · 198d
Cleared Jul 20, 2018
EcoFit Vit E Acetabular System
K180263 · LZO
Implantcast GmbH
Orthopedic · 171d
Cleared Jul 20, 2018
WATCHMAN TruSeal Access System
K180864 · DQY
Boston Scientific
Cardiovascular · 109d
Cleared Jul 20, 2018
TruDi NAV Suction Instruments
K180948 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 100d
Cleared Jul 20, 2018
Free Testosterone AccuBind ELISA Test System
K181017 · CDZ
Monobind, Inc.
Chemistry · 101d
Cleared Jul 20, 2018
GuardianTM Burr Hole Cover System
K181382 · GXR
St Jude Medical
Neurology · 56d