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
22849–22872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2019
Arzzt Distal Radius and Ulna System
K182650 · HRS
Truemed Group, LLC
Orthopedic · 259d
Cleared Jun 10, 2019
Mini Cannulated Headed and Headless Screw Set
K183104 · HWC
Stryker GmbH
Orthopedic · 214d
Cleared Jun 10, 2019
SPINEART Navigation Instrument System
K183630 · OLO
Spineart SA
Orthopedic · 166d
Cleared Jun 10, 2019
Vista FS, Vista FS Liquid
K190220 · MVL
Inter-Med/Vista Dental Products
Dental · 125d
Cleared Jun 10, 2019
AccuFill Bone Substitute Material
K190814 · MQV
Zimmer Knee Creations
Orthopedic · 73d
Cleared Jun 10, 2019
7410 Ultrasound System (MyLabSigma)
K191072 · IYN
Esaote, S.P.A.
Radiology · 49d
Cleared Jun 10, 2019
Insight Essentials DRF Digital Imaging System
K191310 · JAA
Imaging Engineering, LLC
Radiology · 26d
Cleared Jun 09, 2019
SpaceFlex Knee
K190216 · MBB
G21, S.R.L.
Orthopedic · 125d
Cleared Jun 07, 2019
Ceramic Bracket
K180952 · NJM
Mem Dental Technology Co., Ltd.
Dental · 422d
Cleared Jun 07, 2019
tün® ultrasonic tips product family
K182145 · ELC
Engineered Endodontics
Dental · 303d
Cleared Jun 07, 2019
Masimo O3 Regional Oximeter System
K182429 · MUD
Masimo Corporation
Neurology · 274d
Cleared Jun 07, 2019
Miha Bodytec II
K182519 · NGX
Miha Bodytec GmbH
Physical Medicine · 267d
Cleared Jun 07, 2019
Hailie Sensor
K182573 · CAF
Adherium (Nz), Ltd.
Anesthesiology · 262d
Cleared Jun 07, 2019
Argen Clear Aligner
K183229 · NXC
Argen Corporation
Dental · 199d
Cleared Jun 07, 2019
Ivenix Infusion System (IIS)
K183311 · FRN
Ivenix, Inc.
General Hospital · 190d
Cleared Jun 07, 2019
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic...
K183632 · DRF
Baylis Medical Company, Inc.
Cardiovascular · 163d
Cleared Jun 07, 2019
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
K183649 · DRF
Baylis Medical Company, Inc.
Cardiovascular · 163d
Cleared Jun 07, 2019
TD Clip
K190051 · LRK
Zephyr Sleep Technologies, Inc.
Dental · 147d
Cleared Jun 07, 2019
DJO Acetabular System
K190057 · LPH
Encore Medical, L.P.
Orthopedic · 147d
Cleared Jun 07, 2019
RIVAL View Plating Systems and Reduce Fracture Plating Systems
K190388 · HRS
Orthofix Srl
Orthopedic · 108d
Cleared Jun 07, 2019
CeraSeal
K190503 · KIF
Meta Biomed Co., Ltd.
Dental · 98d
Cleared Jun 07, 2019
VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
K190916 · DRG
Vitalconnect, Inc.
Cardiovascular · 59d
Cleared Jun 07, 2019
Andorate Auxiliary Water Connector, Andorate Valves Set
K191231 · ODC
Smartdata Suzhou Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jun 07, 2019
VITROS XT Chemistry Products ALB-TP Slides
K191316 · CIX
Ortho-Clinical Diagnostics, Inc.
Chemistry · 23d