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
8785–8808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 2023
Digital Expert Access with Remote Scanning
K232346 · LNH
Ge Healthcare
Radiology · 84d
Cleared Oct 27, 2023
MeVis Liver Suite
K232045 · JAK
Mevis Medical Solutions AG
Radiology · 109d
Cleared Oct 27, 2023
GIA™ Stapler with Tri-Staple™ Technology
K231934 · GAG
Covidien
General & Plastic Surgery · 119d
Cleared Oct 27, 2023
45 Micron Polyisoprene Condom
K231908 · MOL
Suretex Limited
Obstetrics & Gynecology · 120d
Cleared Oct 27, 2023
PodSKAN HF Diagnostic X-ray System
K231761 · KPR
Skanray Technologies Limited
Radiology · 133d
Cleared Oct 27, 2023
hearOAE
K231545 · EWO
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 150d
Cleared Oct 27, 2023
CoreLink Robotic Navigation Instruments
K231494 · OLO
Corelink, LLC
Orthopedic · 157d
Cleared Oct 27, 2023
Electronic Blood Pressure Monitor
K231310 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 175d
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · LFY
DiaSorin, Inc.
Microbiology · 182d
Cleared Oct 27, 2023
Shina Syringe
K231165 · MEG
Shina Med Corporation
General Hospital · 185d
Cleared Oct 27, 2023
SwiftMR
K230854 · LLZ
Airs Medical, Inc.
Radiology · 213d
Cleared Oct 27, 2023
Modius Sleep
K230826 · QJQ
Neurovalens , Ltd.
Neurology · 217d
Cleared Oct 27, 2023
PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA,...
K230490 · OLP
Dongguan Hunter Electronic Technology...
General & Plastic Surgery · 246d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230300 · JFP
Abbott Point of Care, Inc.
Chemistry · 266d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL
Abbott Point of Care, Inc.
Chemistry · 267d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230275 · JGS
Abbott Point of Care, Inc.
Chemistry · 268d
Cleared Oct 27, 2023
Cold/Hot Compression
K223541 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 336d
Cleared Oct 27, 2023
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459 · PHR
Centrix, Inc.
Dental · 438d
Cleared Oct 27, 2023
Plaxpot Multi Plasma
K220493 · QVJ
Gcs Co. Limited
General & Plastic Surgery · 612d
Cleared Oct 27, 2023
Safety butterfly type blood collection needle, Butterfly type blood...
K213146 · JKA
Jiangsu Rongye Technology Co., Ltd.
General Hospital · 760d
Cleared Oct 26, 2023
AllTest Fentanyl Urine Test Cassette
K233417 · NGL
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 16d
Cleared Oct 26, 2023
PressON Spinal Fixation System
K233234 · NKB
Nexus Spine, LLC
Orthopedic · 28d
Cleared Oct 26, 2023
OGmend® Implant Enhancement System
K233223 · QVI
Woven Orthopedic Technologies
Orthopedic · 28d
Cleared Oct 26, 2023
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP)
K233170 · GXH
AtriCure, Inc.
Neurology · 29d