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
19273–19296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 26, 2020
Adaptix Interbody System with Titan nanoLOCK Surface Technology
K201267 · MAX
Medtronic Sofamor Danek
Orthopedic · 106d
Cleared Aug 26, 2020
VenSure Balloon Device, VenSure Nav Balloon Device
K201472 · LRC
Fiagon GmbH
Ear, Nose, Throat · 84d
Cleared Aug 26, 2020
Motex Anti-Fog Surgical Face Mask
K201549 · FXX
Modern Healthcare Corp.
General Hospital · 78d
Cleared Aug 26, 2020
VersaOne Reusable Positioning Trocar System
K201805 · GCJ
Covidien
General & Plastic Surgery · 56d
Cleared Aug 26, 2020
Provicol QM Aesthetic
K201856 · EMA
Voco GmbH
Dental · 51d
Cleared Aug 26, 2020
Admiral ACP System
K202064 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 30d
Cleared Aug 26, 2020
MindsEye Expandable Port
K202072 · GZT
Minnetronix Neuro, Inc.
Neurology · 30d
Cleared Aug 25, 2020
Injection Pen Needle
K192464 · FMI
Gangan Medical Technology Jiangsu...
General Hospital · 351d
Cleared Aug 25, 2020
Dental Handpiece
K192809 · EFA
Micro-Nx Co., Ltd.
Dental · 329d
Cleared Aug 25, 2020
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes
K193338 · FLL
Shenzhen Med-Link Electronics Tech...
General Hospital · 267d