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
649–672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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
Cleared May 21, 2026
Sphincterotome
K260962 · KNS
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 59d
Cleared May 21, 2026
OES ELITE Cystoscope and Accessories
K260649 · FAJ
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 83d
Cleared May 21, 2026
Ulthera® System
K260618 · OHV
Ulthera, Inc.
General & Plastic Surgery · 85d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 90d
Cleared May 21, 2026
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K260580 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 21, 2026
MSK Go
K260234 · QIH
Smart Alfa Teknoloji San. Ve Tic. A.S.
Radiology · 115d
Cleared May 21, 2026
pjur NATURE Touch, 100 ml
K260068 · NUC
Pjur Group Luxembourg S.A.
Obstetrics & Gynecology · 132d