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
9529–9552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2023
FloNavi Open Field Fluorescence Imaging System
K230407 · OWN
Guangdong Optomedic Technologies, Inc.
General & Plastic Surgery · 152d
Cleared Jul 17, 2023
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
K230395 · FXX
Durio Ppe Sdn Bhd
General Hospital · 153d
Cleared Jul 17, 2023
Arthrex Intramedullary Nails
K230257 · HSB
Arthrex, Inc.
Orthopedic · 167d
Cleared Jul 17, 2023
“POINT” Kinguide Agile Hybrid Navigation System
K230087 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 186d
Cleared Jul 17, 2023
LaserME
K230077 · GEX
Neauvia North America
General & Plastic Surgery · 188d
Cleared Jul 17, 2023
TRULIANT® E-PX Tibial Inserts
K223252 · JWH
Exactech, Inc.
Orthopedic · 269d
Cleared Jul 17, 2023
Fibroid Mapping Reviewer Application (FMRA)
K222683 · LLZ
Nesa Medtech Private Limited
Radiology · 314d
Cleared Jul 17, 2023
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum...
K213953 · JKA
Becton, Dickinson and Company
Chemistry · 577d
Cleared Jul 17, 2023
Pulse Oximeter
K211143 · DQA
Shenzhen Brav Electronic Technologies...
Anesthesiology · 822d
Cleared Jul 16, 2023
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate...
K231460 · KWQ
K&J Consulting Corp.
Orthopedic · 58d
Cleared Jul 14, 2023
PathLoc SI Joint Fusion System
K231841 · OUR
L & K Biomed Co., Ltd.
Orthopedic · 22d
Cleared Jul 14, 2023
FlowSaver Blood Return System (80-101)
K231782 · CAC
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Jul 14, 2023
Ez3D-i /E3
K231757 · QIH
Ewoosoft Co., Ltd.
Radiology · 28d
Cleared Jul 14, 2023
Mobility Scooter (Models: W3431D)
K231428 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 58d
Cleared Jul 14, 2023
NaviNetics Reusable Stereotactic System (NN1000)
K231392 · HAW
Navinetics, Inc.
Neurology · 63d
Cleared Jul 14, 2023
JiveX (Model Number / Release: 5.4)
K231041 · LLZ
Visus Health IT GmbH
Radiology · 93d
Cleared Jul 14, 2023
OnX Tough
K230445 · EBI
Sprintray, Inc.
Dental · 143d
Cleared Jul 14, 2023
Ultraflex™ Tracheobronchial Stent System
K230269 · JCT
Boston Scientific Corporation
Anesthesiology · 164d
Cleared Jul 14, 2023
Cercare Medical Neurosuite
K230016 · LLZ
Cercare Medical A/S
Radiology · 192d
Cleared Jul 14, 2023
Wearable Breast Pump (Model S18)
K223886 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 199d
Cleared Jul 14, 2023
TalWire
K223791 · DQX
Embrace Medical , Ltd.
Cardiovascular · 207d
Cleared Jul 14, 2023
CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
K223290 · LLZ
Sentiar, Inc.
Cardiovascular · 261d
Cleared Jul 14, 2023
Proxeo ULTRA (PB-510, PB-520 and PB-530)
K223173 · ELC
W&H Dentalwerk Buermoss GmbH
Dental · 276d
Cleared Jul 14, 2023
Brainlab Elements Image Fusion, Contouring (4.5)
K223106 · QIH
Brainlab AG
Radiology · 287d