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
7921–7944 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2023
Ankyras
K230006 · PZO
Mentice Spain S.L.
Neurology · 359d
Cleared Dec 27, 2023
TriSalus TriGuideTM Guiding Catheter
K233858 · DQY
Trisalus Life Sciences
Cardiovascular · 22d
Cleared Dec 27, 2023
Colibrí
K232756 · LON
Copan Wasp Srl
Microbiology · 110d
Cleared Dec 27, 2023
EndoSound Vision System
K232518 · ODG
Endosound, Inc.
Gastroenterology & Urology · 131d
Cleared Dec 27, 2023
Nurochek-II System
K231914 · PIW
Headsafe Mfg Pty, Ltd.
Neurology · 181d
Cleared Dec 27, 2023
TearCare MGX System
K231084 · ORZ
Sight Sciences, Inc.
Ophthalmic · 254d
Cleared Dec 26, 2023
Suture Wing
K233659 · MBI
Osteonic Co., Ltd.
Orthopedic · 41d
Cleared Dec 26, 2023
Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen...
K233515 · NQJ
Nuwellis, Inc.
Gastroenterology & Urology · 55d
Cleared Dec 26, 2023
POWEReam 1/4 Drive
K233300 · NKB
Stryker Instruments
Orthopedic · 88d
Cleared Dec 26, 2023
BTL-899M
K232937 · IPF
BTL Industries, Inc.
Physical Medicine · 97d
Cleared Dec 26, 2023
TumorSight Viz
K231130 · QIH
SimBioSys, Inc.
Radiology · 250d
Cleared Dec 22, 2023
3M™ Transbond™ Orthodontic Adhesive
K234043 · DYH
3M Unitek Orthodontic Products
Dental · 1d
Cleared Dec 22, 2023
CloudTMS Edge for OCD
K233742 · QCI
Teleemg, LLC
Neurology · 30d
Cleared Dec 22, 2023
Interson USB Ultrasound System
K233734 · IYN
Interson Corporation
Radiology · 30d
Cleared Dec 22, 2023
Omnimax S3, Omnimax S4
K233304 · GEX
Sharplight Technologies, Ltd.
General & Plastic Surgery · 84d
Cleared Dec 22, 2023
Anthogyr INTEGRAL Guided Surgery Cassettes
K233264 · KCT
Anthogyr
General Hospital · 84d
Cleared Dec 22, 2023
Distal Access Catheter
K233205 · QJP
Shanghai Heartcare Medical Technology...
Neurology · 85d
Cleared Dec 22, 2023
TP Pivot Pro™ Needle Guide
K233109 · ITX
Civco Medical Solutions
Radiology · 86d
Cleared Dec 22, 2023
SofWave System
K233104 · OHV
Sofwave Medical, Ltd.
General & Plastic Surgery · 87d
Cleared Dec 22, 2023
TopCEM Dual Cure Resin Cement
K233082 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 87d
Cleared Dec 22, 2023
VivaChek Link Plus Blood Glucose Monitoring System
K233058 · NBW
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 88d
Cleared Dec 22, 2023
NanoZoomer S360MD Slide scanner system
K233027 · PSY
Hamamatsu Photonics K.K.
Pathology · 88d
Cleared Dec 22, 2023
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood...
K232881 · JKA
Jiangsu Kangbao Medical Equipment...
General Hospital · 95d
Cleared Dec 22, 2023
VIO System (V-1000)
K232789 · QZN
Enspectra Health, Inc.
General & Plastic Surgery · 102d