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

Filters: Cleared only ×
175,820 results
26689–26712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2018
ACISTCVi® Contrast Delivery System
K171646 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 256d
Cleared Feb 16, 2018
NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
K172208 · BTR
Nevap, Inc.
Anesthesiology · 207d
Cleared Feb 16, 2018
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae)...
K172348 · LSW
Aesku.Diagnostics GmbH & Co. KG
Immunology · 197d
Cleared Feb 16, 2018
EEA Circular Stapler with Tri-Staple Technology
K172361 · GDW
Covidien
General & Plastic Surgery · 196d
Cleared Feb 16, 2018
Needle Free Transseptal Cannula
K172934 · DRC
Pressure Products Medical Device...
Cardiovascular · 144d
Cleared Feb 16, 2018
Wireless Audio System
K173409 · LNH
Neocoil, LLC
Radiology · 107d
Cleared Feb 16, 2018
NeuroEEG
K173460 · GWQ
Memory MD, Inc.
Neurology · 101d
Cleared Feb 16, 2018
Magseed Magnetic Marker Systtem
K173587 · NEU
Endomagnetics Ltd.,
General & Plastic Surgery · 88d
Cleared Feb 16, 2018
Breast BI 7 MR Coil 1.5T Mammavention
K180123 · MOS
Noras Mri Products GmbH
Radiology · 31d
Cleared Feb 16, 2018
Warrior 14 guidewire
K180128 · DQX
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Feb 16, 2018
SPIWay Endonasal Access Guide
K180141 · LYA
Spiway, LLC
Ear, Nose, Throat · 29d
Cleared Feb 15, 2018
SURGICAL ISOLATION GOWN
K171535 · FYC
Jingzhou Haixin Green Cross Medical...
General Hospital · 266d
Cleared Feb 15, 2018
Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube...
K171604 · LKF
Cook Incorporated
Obstetrics & Gynecology · 259d
Cleared Feb 15, 2018
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
K172613 · PCN
The Binding Site Group , Ltd.
Immunology · 168d
Cleared Feb 15, 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · KHE
Alfa Scientific Designs, Inc.
Hematology · 136d
Cleared Feb 15, 2018
CorPath GRX System
K173288 · DXX
Corindus, Inc.
Cardiovascular · 122d
Cleared CT Feb 15, 2018
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
K173352 · POL
Concentric Medical, Inc.
Neurology · 113d
Cleared Feb 15, 2018
Vinyl Patient Examination Glove (Yellow)
K173580 · LYZ
Nature Medical Products Co., Ltd.
General Hospital · 87d
Cleared Feb 15, 2018
Velocity
K173636 · LLZ
Varian Medical Systems, Inc.
Radiology · 83d
Cleared Feb 15, 2018
Gazelle Polypropylene Suture and Delivery Device
K173644 · GAW
Dura Tap, LLC
General & Plastic Surgery · 80d
Cleared Feb 15, 2018
Prelude IDeal Hydrophilic Sheath Introducer
K173750 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 69d
Cleared Feb 15, 2018
BOWA Neutral Electrodes
K173877 · GEI
Bowa-Electronics GmbH & Co. KG
General & Plastic Surgery · 56d
Cleared Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM...
K180137 · GEH
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO2)
K180138 · GXH
AtriCure, Inc.
Neurology · 29d