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
7297–7320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2024
NeuroStar Advanced Therapy System (All previously cleared models)
K231926 · OBP
Neuronetics, Inc.
Neurology · 266d
Cleared Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · JTN
Oxoid Limited (Part of Thermo Fisher...
Microbiology · 276d
Cleared Mar 22, 2024
QuickVue COVID-19 Test
K231795 · QYT
Quidel Corporation
Microbiology · 276d
Cleared Mar 21, 2024
N2
K240754 · EIA
Megagen Implant Co., Ltd.
Dental · 1d
Cleared Mar 21, 2024
DynaNail Mini Tapered Hybrid
K240530 · HWC
MedShape, Inc.
Orthopedic · 27d
Cleared Mar 21, 2024
Tandem Mobi insulin pump with interoperable technology
K240309 · QFG
Tandem Diabetes Care, Inc.
Chemistry · 48d
Cleared Mar 21, 2024
Reach Needle
K240253 · BSP
Aerin Medical, Inc.
Anesthesiology · 51d
Cleared Mar 21, 2024
Medical Diode Laser (Model: L2)
K240179 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Mar 21, 2024
Normatec Elite
K240122 · IRP
NormaTec Industries, LP
Physical Medicine · 65d
Cleared Mar 21, 2024
RedDrop ONE (One)
K234081 · FMK
Reddrop DX
General & Plastic Surgery · 90d
Cleared Mar 21, 2024
APTUS Hand Scaphoid Plates
K234062 · HRS
Medartis AG
Orthopedic · 90d
Cleared Mar 21, 2024
AllSource Drug Detector FenTest
K234006 · NGL
Allsource Screening Solutions
Toxicology · 93d
Cleared Mar 21, 2024
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb...
K233980 · KRO
Depuy Ireland UC
Orthopedic · 94d
Cleared Mar 21, 2024
accufit
K233926 · IPF
Mettler Electronics Corporation
Physical Medicine · 99d
Cleared Mar 21, 2024
AI-Rad Companion (Pulmonary)
K233753 · JAK
Siemens Healthcare GmbH
Radiology · 120d
Cleared Mar 21, 2024
DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small...
K233665 · HRS
DePuy Synthes
Orthopedic · 127d
Cleared Mar 21, 2024
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
K232568 · GEX
Ipg Medical Corporation
Gastroenterology & Urology · 210d
Cleared Mar 21, 2024
Electrical Stimulator System
K232439 · NUH
Gymmax Technology Shenzen Co., Ltd.
Neurology · 220d
Cleared Mar 21, 2024
Ankle Truss System (ATS)
K230088 · SAI
4Web Medical, Inc.
Orthopedic · 434d
Cleared Mar 20, 2024
Peak Universal Bond
K240743 · KLE
Ultradent Products, Inc.
Dental · 2d
Cleared Mar 20, 2024
BruxZir® Radiant
K240574 · EIH
Prismatik Dentalcraft, Inc.
Dental · 19d
Cleared Mar 20, 2024
SMARTXIDE PRO
K240537 · GEX
El.En S.P.A.
General & Plastic Surgery · 23d
Cleared Mar 20, 2024
NuVasive AttraX Scaffold
K240507 · MQV
Nuvasive, Inc.
Orthopedic · 28d
Cleared Mar 20, 2024
Aneroid Sphygmomanometer with Stethoscope
K240165 · DXQ
Wenzhou Longwan Medical Device Factory
Cardiovascular · 58d