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
17809–17832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 2021
PleuraFlow System with FlowGlide
K203394 · OTK
Clearflow, Inc.
General & Plastic Surgery · 104d
Cleared Mar 02, 2021
MaxFOV 2
K203617 · JAK
Ge Medical Systems, LLC
Radiology · 81d
Cleared Mar 02, 2021
MRI PPG Patient Cable
K203653 · LNH
Ivy Biomedical Systems, Inc.
Radiology · 77d
Cleared Mar 02, 2021
Shoulder System - TiNbN Coating
K203755 · PHX
Medacta International S.A.
Orthopedic · 69d
Cleared Mar 02, 2021
GMK Revision & Hinge Extension - TiNbN Coating
K210010 · KRO
Medacta International S.A.
Orthopedic · 57d
Cleared Mar 02, 2021
OverStitch Sx Endoscopic Suturing System
K210266 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 29d
Cleared Mar 02, 2021
Mars1717X Wireless Digital Flat Panel Detector
K210314 · MQB
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Mar 01, 2021
Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes
K201533 · KCT
Avinent Implant System S.L.U.
General Hospital · 266d
Cleared Mar 01, 2021
Getinge GSS610N Series Steam Sterilizer
K201927 · FLE
Maquet GmbH
General Hospital · 234d
Cleared Mar 01, 2021
imani i2
K202037 · HGX
Imani Co.
Obstetrics & Gynecology · 221d
Cleared Mar 01, 2021
Nitrile Examination Gloves (Blue, Violet Blue, White)
K202402 · LZA
Jiangsu Tianshuo Medical Products...
General Hospital · 192d
Cleared Mar 01, 2021
OMNI Surgical System
K202678 · MRH
Sight Sciences, Inc.
Ophthalmic · 167d
Cleared Mar 01, 2021
Med-Link Temp-pulse Oximeter
K202743 · DQA
Shenzhen Med-Link Electronics Tech...
Anesthesiology · 164d
Cleared Mar 01, 2021
Fingertip pulse oximeter
K202776 · DQA
Shenzhen Lepu Intelligent Medical...
Anesthesiology · 161d
Cleared Mar 01, 2021
Recon Support Catheter
K203275 · DQY
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared CT Mar 01, 2021
Solitaire X Revascularization Device
K203358 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 105d
Cleared Mar 01, 2021
NuVasive Modulus ALIF System
K210271 · OVD
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared Mar 01, 2021
VALO Grand Corded and Accessory Lenses
K210550 · EBZ
Ultradent Products, Inc.
Dental · 4d
Cleared Feb 28, 2021
QardioCore
K201644 · DSH
Qardio, Inc.
Cardiovascular · 256d
Cleared Feb 26, 2021
Archworx
K173738 · NXC
Utah Medical Products and Services
Dental · 1178d
Cleared Feb 26, 2021
ASI Plethysmogrpah Analyzer
K200567 · JOM
Arterial Stiffness, Inc.
Cardiovascular · 359d
Cleared Feb 26, 2021
AsoAligner
K201104 · NXC
Aso International Manila, Inc.
Dental · 308d
Cleared Feb 26, 2021
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
K201316 · IYO
Suzhou Peaksonic Medical Technology...
Radiology · 284d
Cleared Feb 26, 2021
Ultrafast, Ultrafast Plus, Ultrafast Lite
K201387 · NVK
Dentlight, Inc.
Dental · 275d