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
5281–5304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2024
Vivo 1, Vivo 2
K240778 · MNS
Breas Medical AB
Anesthesiology · 267d
Cleared Dec 13, 2024
731 Series Ventilator
K233486 · CBK
ZOLL Medical Corporation
Anesthesiology · 413d
Cleared Dec 13, 2024
Bioscope Neuromonitor Device
K233001 · ETN
Biosys Biyomedikal Muhendislik San....
Ear, Nose, Throat · 448d
Cleared Dec 13, 2024
HeartBeam AIMIGo(TM) System
K231424 · MWJ
Heartbeam, Inc.
Cardiovascular · 576d
Cleared Dec 12, 2024
Mac-Lab (AltiX AI.i)
K243540 · DQK
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Dec 12, 2024
uMI Panvivo (uMI Panvivo)
K243538 · KPS
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Dec 12, 2024
Natus Ultrapro S100 (982A0594)
K243495 · GWF
Natus Neurology Incorporated
Neurology · 30d
Cleared Dec 12, 2024
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
K242934 · KIF
Longly Biotechnology (Wuhan) Co., Ltd.
Dental · 78d
Cleared Dec 12, 2024
NExT Station
K242832 · GWL
Eb Neuro S.P.A.
Neurology · 84d
Cleared Dec 12, 2024
Terragene® Bionova® Photon Process Challenge Device with unique-point...
K242453 · FRC
Terragene S.A.
General Hospital · 115d
Cleared Dec 12, 2024
EPIQ Series Diagnostic Ultrasound System
K242020 · IYN
Philips Ultrasound, LLC
Radiology · 154d
Cleared Dec 12, 2024
Infrascanner Model 2500 (Model 2500)
K241389 · OPT
Infrascan, Inc.
Neurology · 211d
Cleared Dec 12, 2024
Aqua Medical RF Vapor Ablation System
K241271 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 220d
Cleared Dec 12, 2024
Medicon Epiplating System
K241253 · FZE
Cmf Medicon Surgical, Inc.
General & Plastic Surgery · 223d
Cleared Dec 12, 2024
visio.lign color, visio.lign shield
K240735 · EBD
Bredent GmbH & Co. KG
Dental · 269d
Cleared Dec 12, 2024
GENIOVA aligners
K233152 · NXC
Geniova Technologies Sociedad Limitada
Dental · 442d
Cleared Dec 11, 2024
BriefCase-Triage
K243548 · QFM
Aidoc Medical , Ltd.
Radiology · 26d
Cleared Dec 11, 2024
Alinity c Benzodiazepines Reagent Kit
K243498 · JXM
Microgenics Corporation
Toxicology · 29d
Cleared Dec 11, 2024
SternalPlate Expansion
K243491 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 29d
Cleared Dec 11, 2024
Cervical Plating System
K243369 · KWQ
Life Spine, Inc.
Orthopedic · 42d
Cleared Dec 11, 2024
FAQ™ (302)
K242747 · OAP
Foreo, Inc.
General & Plastic Surgery · 90d
Cleared Dec 11, 2024
VECTR – Video Endoscopic Carpal Tunnel Release System
K242417 · HRX
Rafael Medical Devices, LLC
Orthopedic · 118d
Cleared Dec 11, 2024
Eclipse Treatment Planning System (18.1)
K242378 · MUJ
Varian Medical Systems
Radiology · 124d
Cleared Dec 11, 2024
TECHFIT DISRP® System
K242263 · DZJ
Techfit Digital Surgery, Inc.
Dental · 132d