FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
3073–3096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 15, 2025
Jewel Soft Tissue Reinforcement Device (102-6005)
K242237 · QUW
Xiros Limited
Orthopedic · 350d
Cleared Jul 14, 2025
Phantom® Hindfoot TTC/TC Nail System
K251850 · HSB
Paragon 28, Inc.
Orthopedic · 28d
Cleared Jul 14, 2025
Materialise TKA Guide System
K251554 · JWH
Materialise NV
Orthopedic · 54d
Cleared Jul 14, 2025
FLOWRUNNER Aspiration System
K251488 · QEZ
Expanse Medical, Inc.
Cardiovascular · 61d
Cleared Jul 14, 2025
CoolTone
K251378 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 73d
Cleared Jul 14, 2025
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD,...
K251173 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 89d
Cleared Jul 14, 2025
The Acumed Wrist Fixation System - Plates
K251132 · HRS
Acumed, LLC
Orthopedic · 94d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 14, 2025
LUMINOS Q.namix T
K250660 · OWB
Siemens Medical Solutions
Radiology · 131d
Cleared Jul 14, 2025
Leonardo Duster
K250504 · GEX
Ceramoptec GmbH
General & Plastic Surgery · 144d
Cleared Jul 14, 2025
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19,...
K250185 · DXN
Jiangxi Aicare Medical Technology...
Cardiovascular · 173d