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: 2026–2026 ×
1,922 results
649–672 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 22, 2026
da Vinci Firefly Imaging System
K260695 · NAY
Intuitive Surgical
General & Plastic Surgery · 80d
Cleared May 22, 2026
Apollo TMS Therapy System
K260560 · OBP
Mag & More GmbH
Neurology · 92d
Cleared May 22, 2026
Ion-C Navigation Instruments
K260329 · OLO
SurGenTec, LLC
Orthopedic · 112d
Cleared May 22, 2026
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning
K260324 · QIH
Canon Medical Informatics, Inc.
Radiology · 112d
Cleared May 22, 2026
MagVenture Accelerated TMS (aTMS) Therapy System
K260189 · OBP
Tonica Elektronik A/S
Neurology · 120d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared May 22, 2026
InQwire Amplatz Guide Wire
K254137 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 151d
Cleared May 22, 2026
Spectrum-2
K254129 · MUD
Neko Health AB
General & Plastic Surgery · 151d
Cleared May 22, 2026
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort...
K253949 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 163d
Cleared May 22, 2026
Guanhong Sharps Container (GHW-1F1)
K253773 · MMK
Taizhou Huangyan Guanhong Plastic...
General Hospital · 177d
Cleared May 22, 2026
Atmo Gas Capsule System
K253569 · NYV
Atmo Biosciences, Ltd.
Gastroenterology & Urology · 186d
Cleared May 22, 2026
Zenith Distal Access Long Sheath
K253359 · QJP
Suzhou Zenith Vascular SciTech Limited
Neurology · 234d
Cleared May 22, 2026
Sterile Latex Powder Free Surgical Gloves
K253060 · KGO
Protect Gloves Company Limited
General Hospital · 242d
Cleared May 22, 2026
ATLAAS (Atraumatic Left Atrial Appendage System) (AD)
K252917 · PZX
Genesee Biomedical, Inc.
Cardiovascular · 252d
Cleared May 22, 2026
AiSteth®
K252915 · DQD
Ai Health Highway India Pvt., Ltd.
Cardiovascular · 252d
Cleared May 22, 2026
DePuy ATTUNE™ Knee System
K252887 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 254d
Cleared May 22, 2026
eXaSkin Plus
K252784 · MUJ
Anatomical Geometry S.L.
Radiology · 262d
Cleared May 22, 2026
Arc Adjustable Radial Cuff Compression Device
K252772 · DXC
Tz Medical, Inc.
Cardiovascular · 262d
Cleared May 22, 2026
C-beam
K252735 · OWB
Pulmera, Inc.
Radiology · 267d
Not Cleared May 22, 2026
PCWP Analysis Software
DEN250057 · SIF
Cardiosense, Inc.
Cardiovascular · 186d
Cleared May 21, 2026
Stelo Glucose Biosensor System
K261359 · SAF
Dexcom, Inc.
Chemistry · 27d
Cleared May 21, 2026
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU,...
K261325 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 29d
Cleared May 21, 2026
Symbia Pro.specta Q3 (11364751)
K261315 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared May 21, 2026
Nisus NPWT Canister 500-mL (CPC-500)
K261291 · OMP
Cork Medical
General & Plastic Surgery · 31d