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
2185–2208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2025
Electric Breast Pump (HL-3058, F5112)
K252629 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 68d
Cleared Oct 27, 2025
Disposable Vinyl Examination Gloves
K252467 · LYZ
Viet Phu Trade and Import Export Co.,...
General Hospital · 82d
Cleared Oct 27, 2025
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
K252053 · OHS
Touchbeauty Beauty & Health...
General & Plastic Surgery · 118d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Affinity Biosensors, LLC
Microbiology · 131d
Cleared Oct 27, 2025
Patriot Duo
K251824 · GEX
Patriot Laser, LLC
General & Plastic Surgery · 136d
Cleared Oct 27, 2025
Blood Pressure Monitor (B73, BE23T)
K251331 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 180d
Cleared Oct 27, 2025
cvi42 Coronary Plaque Software Application
K251027 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 208d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Oct 27, 2025
TECHFIT Patient-Specific Cranial System
K250297 · GWO
Techfit Digital Surgery, Inc.
Neurology · 269d
Cleared Oct 24, 2025
Expandable Titanium PLIF/TLIF System
K253377 · MAX
Spectrum Spine, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
CD Horizon™ Spinal System
K253335 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
CoaguChek XS Plus System
K253188 · GJS
Roche Diagnostics
Hematology · 28d
Cleared Oct 24, 2025
Cryon-X Cold Compression
K253150 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 29d
Cleared Oct 24, 2025
Infinity™ OCT System
K253129 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125 · FTL
Medtronic - Sofradim Production
General & Plastic Surgery · 29d
Cleared Oct 24, 2025
AngioVac Cannula
K253106 · DWF
AngioDynamics, Inc.
Cardiovascular · 30d
Cleared Oct 24, 2025
Fule Spinal Fixation System
K252730 · NKB
Beijing Fule Science & Technology...
Orthopedic · 57d
Cleared Oct 24, 2025
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
K252646 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 64d
Cleared Oct 24, 2025
LumiGuide Equipment R2.1
K252645 · DQK
Philips Medical Systems Nederland B.V.
Cardiovascular · 64d
Cleared Oct 24, 2025
Glucose2
K252357 · CFR
Abbott Ireland
Chemistry · 87d
Cleared Oct 24, 2025
CoroFlow Cardiovascular System
K252238 · DQK
Coroventis Research AB
Cardiovascular · 99d
Cleared Oct 24, 2025
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
K252044 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Oct 24, 2025
Arctic Sun Temperature Management System (Model 5000)
K251974 · DWJ
Medivance, Inc.
Cardiovascular · 120d
Cleared Oct 24, 2025
Azurion R3.1
K251827 · OWB
Philips Medical Systems B.V.
Radiology · 133d