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

Filters: Cleared only ×
175,230 results
18673–18696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2020
DreaMed Advisor Pro
K201476 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 86d
Cleared Aug 28, 2020
AOS Galileo™ Trochanteric Nail System
K202099 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 30d
Cleared Aug 28, 2020
External Counterpulsation System, Soulaire
K202108 · DRN
Vamed Medical Instrument Co., Ltd.
Cardiovascular · 29d
Cleared Aug 28, 2020
SpaceOAR System
K202224 · OVB
Boston Scientific Corporation
Radiology · 21d
Cleared Aug 27, 2020
Konix Anti-Fog Solution
K190864 · OCT
Turkuaz Saglik Hizmetleri Medikal...
Gastroenterology & Urology · 512d
Cleared Aug 27, 2020
Nucleoss T6 Dental Implant System
K192062 · DZE
Sanlilar Tibbi Cihazlar Medikal Kimya...
Dental · 392d
Cleared Aug 27, 2020
APTOS Threads – Polypropylene Surgical Sutures
K192953 · GAW
Aptos, LLC
General & Plastic Surgery · 311d
Cleared Aug 27, 2020
Oral-B iO Test Drive Power Brush Trial Program Kit
K200881 · JEQ
The Procter & Gamble Company
Dental · 147d
Cleared Aug 27, 2020
Synapse 3D Cardiac Tools
K200973 · LLZ
Fujifilm Corporaton
Radiology · 136d
Cleared Aug 27, 2020
Next Generation Balloon Dilation System
K201115 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 122d
Cleared Aug 27, 2020
Essence 55SP Large Monitor System
K201162 · DXJ
Shenyang Torch-Bigtide Digital...
Cardiovascular · 119d
Cleared Aug 27, 2020
ANCORIS
K201807 · KPS
Miegmbh
Radiology · 57d
Cleared Aug 27, 2020
ANSER Clavicle Pin
K201830 · HSB
BAAT Medical Products B.V.
Orthopedic · 56d
Cleared Aug 27, 2020
Magicore System
K201981 · DZE
Innobiosurg Co., Ltd.
Dental · 42d
Cleared Aug 26, 2020
TK Intravascular Administration Set
K191640 · FPA
Anhui Tiankang Medical Technology...
General Hospital · 434d
Cleared Aug 26, 2020
MONDRIAN Lumbar Interbody Fusion Cage System
K192863 · MAX
Ctl Medical Corporation
Orthopedic · 324d
Cleared Aug 26, 2020
CER-S
K193177 · MLO
Cardiocalm
Cardiovascular · 282d
Cleared Aug 26, 2020
Hydrophilic Coating Guide Wire
K193653 · DQX
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 240d
Cleared Aug 26, 2020
Deltaven Fast Flash Closed I.V. Catheter Systems
K200373 · FOZ
Delta Med Spa
General Hospital · 194d
Cleared Aug 26, 2020
AVIEW
K200714 · LLZ
Coreline Soft Co., Ltd.
Radiology · 161d
Cleared Aug 26, 2020
Emprint Ablation System with Thermosphere Technology
K200796 · NEY
Covidien, LLC
General & Plastic Surgery · 153d
Cleared Aug 26, 2020
Single-use Surgical Mask
K200923 · FXX
Byd Precision Manufacturer Co., Ltd.
General Hospital · 141d
Cleared Aug 26, 2020
BriefCase
K201020 · QAS
Aidoc Medical , Ltd.
Radiology · 131d
Cleared Aug 26, 2020
FIRMM
K201141 · LNH
Nous Imaging, Inc.
Radiology · 119d