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
3337–3360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2025
DualView Catheter
K250751 · DQO
Terumo Corporation
Cardiovascular · 127d
Cleared Jul 17, 2025
0.014” Willow Guidewire
K243756 · MOF
Arbor Endovascular, LLC
Neurology · 223d
Cleared Jul 17, 2025
uMR Ultra
K243547 · LNH
Shanghai United Imaging Healthcare...
Radiology · 244d
Cleared Jul 17, 2025
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G...
K243428 · MOS
Dxtx Medical, Inc.
Radiology · 254d
Cleared Jul 17, 2025
HESTIA
K243420 · MUE
Genoray Co., Ltd.
Radiology · 255d
Cleared Jul 17, 2025
Masimo O3 Regional Oximeter
K243324 · MUD
Masimo Corporation
General & Plastic Surgery · 267d
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505 · JFT
Roche Diagnostics
Chemistry · 329d
Cleared Jul 16, 2025
Marigen Wound Extra
K251845 · KGN
Kerecis Limited
General & Plastic Surgery · 30d
Cleared Jul 16, 2025
EchoPAC Software Only / EchoPAC Plug-in
K251342 · QIH
GE Medical Systems Ultrasound and...
Radiology · 77d
Cleared Jul 16, 2025
da Vinci Surgical System (IS5000)
K251202 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 16, 2025
HyperVue™ Software
K251198 · NQQ
Spectrawave, Inc.
Cardiovascular · 90d
Cleared Jul 16, 2025
Rapid CTA 360
K251151 · QAS
Ischemaview
Radiology · 93d
Cleared Jul 16, 2025
Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L,...
K251102 · DXN
Cemho Medical Technology (Guangdong)...
Cardiovascular · 96d
Cleared Jul 16, 2025
Suction Valve (MAJ-1443)
K250949 · ODC
Olympus Medical Systems Corporation
Gastroenterology & Urology · 110d
Cleared Jul 16, 2025
StimTrial Neuromodulation System
K243782 · GZF
Bioventus, LLC
Neurology · 219d
Cleared Jul 16, 2025
ARCHIMEDES Biodegradable Pancreatic Stent
K243412 · FGE
Q3 Medical USA, LLC (C/O Q3 Medical...
Gastroenterology & Urology · 257d
Cleared Jul 16, 2025
uMR 680
K243397 · LNH
Shanghai United Imaging Healthcare...
Radiology · 258d
Cleared Jul 15, 2025
Kerecis SurgiBind (50241)
K251844 · OXH
Kerecis Limited
General & Plastic Surgery · 29d
Cleared Jul 15, 2025
Shinetell PlusTM Digital Early Pregnancy Test
K251053 · LCX
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 102d
Cleared Jul 15, 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
K251045 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 103d
Cleared Jul 15, 2025
Thrive 2-in-1 Breast Pump (Model P3)
K250350 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 158d
Cleared Jul 15, 2025
AV Viewer
K250181 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 174d
Cleared Jul 15, 2025
Tempus ECG-Low EF
K250119 · QYE
Tempus AI, Inc.
Cardiovascular · 180d
Cleared Jul 15, 2025
IsoSphere
K242818 · KXK
Isoaid, LLC
Radiology · 300d