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
25009–25032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 2018
syngo.via View&GO (Version VA10A)
K182208 · LLZ
Siemens Healthcare GmbH
Radiology · 23d
Cleared Sep 07, 2018
Multi Modality Viewer
K182230 · LLZ
Vital Images, Inc.
Radiology · 21d
Cleared Sep 07, 2018
RetCam 3
K182263 · HKI
Natus Medical Incorporated
Ophthalmic · 17d
Cleared Sep 06, 2018
Dual output digital therapy massager
K172834 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 352d
Cleared Sep 06, 2018
Trabis
K173893 · PLR
Coligne AG
Orthopedic · 259d
Cleared Sep 06, 2018
Provata Implant System
K180465 · DZE
Southern Implants (Pty), Ltd.
Dental · 197d
Cleared Sep 06, 2018
Spinal Elements Cerclage System
K180728 · OWI
Spinal Elements, Inc.
Orthopedic · 170d
Cleared CT Sep 06, 2018
Paladin Carotid Post-dilation Balloon System with Integrated Embolic...
K181128 · LIT
Contego Medical, LLC
Cardiovascular · 129d
Cleared CT Sep 06, 2018
Sebacia Microparticles
K181518 · QCY
Sebacia, Inc.
General & Plastic Surgery · 90d
Cleared Sep 06, 2018
Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors...
K181558 · LPL
Gelflex Laboratories
Ophthalmic · 85d
Cleared Sep 06, 2018
Ultrasound System SONIMAGE HS1
K182153 · IYO
Konica Minolta, Inc.
Radiology · 29d
Cleared Sep 06, 2018
Optima XR240amx
K182234 · IZL
Ge Medical Systems, LLC
Radiology · 20d
Cleared Sep 05, 2018
AMSafe Sure-Lok Needle-Free Connector
K173665 · FPA
Amsino International, Inc.
General Hospital · 280d
Cleared Sep 05, 2018
HD-500 Video Endoscope System
K173921 · NWB
Sonoscape Medical Corp.
Gastroenterology & Urology · 253d
Cleared Sep 05, 2018
Masimo Acoustic Respiration Sensors, infant and neonate
K173976 · BZQ
Masimo Corporation
Anesthesiology · 250d
Cleared Sep 05, 2018
Iridex TruFocus LIO Premiere
K181662 · GEX
Iridex Corporation
Ophthalmic · 72d
Cleared Sep 05, 2018
Kiierr 272 Laser, Kiierr 148 Laser
K181878 · OAP
Kiierr International, LLC
General & Plastic Surgery · 54d
Cleared Sep 05, 2018
Precise Treatment System
K182138 · IYE
Eleckta Limited
Radiology · 29d
Cleared Sep 04, 2018
NeoBase 2 Non-derivatized MSMS Kit
K173568 · NQL
Wallac Oy, Subsidiary of Perkinelmer,...
Chemistry · 288d
Cleared Sep 04, 2018
Surveyor Patient Monitor
K173765 · MHX
Mortara Instrument, Inc.
Cardiovascular · 267d
Cleared Sep 04, 2018
EUSRA RF Electrode
K181249 · GEI
Starmed Co., Ltd.
General & Plastic Surgery · 117d
Cleared Sep 04, 2018
IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3,...
K181314 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 110d
Cleared Sep 04, 2018
ECHOLASER X4
K181510 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 88d
Cleared Sep 04, 2018
Exactech Alteon Monobloc Revision Stem
K181532 · LZO
Exactech, Inc.
Orthopedic · 85d