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
2929–2952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2025
Deepsight NeedleVue LC1 Ultrasound System
K250381 · IYO
DeepSight Technology, Inc.
Radiology · 171d
Cleared Aug 01, 2025
RONAVIS – FX (FX-001)
K250315 · HTY
AIRS, Inc.
Orthopedic · 178d
Cleared Aug 01, 2025
Sparta Infusion Set for Insulin
K243841 · FPA
Deka Research and Development
Chemistry · 231d
Cleared Aug 01, 2025
MycoMEIA Aspergillus Assay
K243496 · NOM
Pearl Diagnostics, Inc.
Microbiology · 262d
Cleared Aug 01, 2025
Access hsTnI
K243483 · MMI
Beckman Coulter, Inc.
Chemistry · 266d
Cleared Aug 01, 2025
Diazyme Colorimetric Lithium Assay
K243462 · NDW
Diazyme Laboratories, Inc.
Chemistry · 266d
Cleared Aug 01, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243458 · LJS
Access Vascular, Inc.
General Hospital · 266d
Cleared Aug 01, 2025
Equinoxe® Shoulder System
K243448 · PHX
Exactech, Inc.
Orthopedic · 267d
Cleared Aug 01, 2025
QuickSleeper 5
K243427 · EGM
Dentalhitec
Dental · 269d
Cleared Jul 31, 2025
Sleep Watch
K251574 · LEL
Ambulatory Monitoring, Inc.
Neurology · 70d
Cleared Jul 31, 2025
Biograph Trinion
K251561 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 71d
Cleared Jul 31, 2025
Wearable Breast Pump (Model FS12A)
K250843 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 133d
Cleared Jul 31, 2025
YSIO X.pree
K250738 · KPR
Siemens Medical Solutions
Radiology · 142d
Cleared Jul 31, 2025
REMEX Xcam6
K250597 · IZL
Remedi, Inc.
Radiology · 153d
Cleared Jul 31, 2025
NextAR(TM) Spine
K250477 · SBF
Medacta International S.A.
Orthopedic · 162d
Cleared Jul 31, 2025
eCO2 3D
K244060 · ONG
Lutronic Corporation
General & Plastic Surgery · 212d
Cleared Jul 31, 2025
U2 Total Knee System – PF+ Patella
K243656 · MBH
United Orthopedic Corporation
Orthopedic · 247d
Cleared Jul 31, 2025
Trabecular Metal Acetabular Revision System, Acetabular Liners and...
K243571 · JDI
Zimmer Biomet
Orthopedic · 255d
Cleared Jul 31, 2025
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
K243455 · QOF
Roche Molecular Systems, Inc.
Microbiology · 266d
Cleared Jul 31, 2025
Genius AI Detection 2.0
K243341 · QDQ
Hologic, Inc.
Radiology · 279d
Cleared Jul 31, 2025
BeneVision Central Monitoring System
K242728 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 324d
Cleared Jul 31, 2025
Mpact Constrained Liner
K241461 · KWZ
Medacta International S.A.
Orthopedic · 434d
Cleared Jul 30, 2025
Iconix Speed Anchor
K252144 · MBI
Riverpoint Medical
Orthopedic · 22d
Cleared Jul 30, 2025
T65 (9016E061-)
K252032 · OBP
Tonica Elektronik A/S
Neurology · 30d