FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
481–504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2026
Transpara (2.1.0)
K260898 · QDQ
Screenpoint Medical B.V.
Radiology · 149d
Cleared Aug 14, 2026
NHanceIT
K260559 · DQY
IMDS Operation B.V.
Cardiovascular · 176d
Cleared Aug 14, 2026
Vital Signs Monitor (CLEO2)
K260438 · MWI
Infinium Medical, Inc.
Cardiovascular · 184d
Cleared Aug 14, 2026
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring
K260374 · GYD
Empatica S.R.L.
Neurology · 190d
Cleared Aug 14, 2026
Portable Oxygen Concentrator (PO1 5B, PO1 6B)
K260171 · CAW
BMC Medical Co., Ltd.
Anesthesiology · 205d
Cleared Aug 14, 2026
Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
K253747 · FMF
Jiangsu Enjosim Medical Technology...
General Hospital · 262d
Cleared Aug 14, 2026
medilogFD
K253562 · MWJ
Schiller AG
Cardiovascular · 270d
Cleared Aug 13, 2026
CEREGLIDE 57 Intermediate Catheter
K262398 · NRY
Cerenovus, Inc.
Neurology · 30d
Cleared Aug 13, 2026
UltraPrint Flexible Denture UV
K261626 · EBI
Guangzhou Heygears IMC., Inc.
Dental · 90d
Cleared Aug 13, 2026
TrachFlush
K261499 · BSK
Aw Technologies Aps
Anesthesiology · 99d
Cleared Aug 13, 2026
VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
K261139 · GCJ
Freyja Healthcare, LLC
General & Plastic Surgery · 128d
Cleared Aug 13, 2026
BP Go (BPP-855)
K261061 · DXN
Wellvii, Inc.
Cardiovascular · 135d
Cleared Aug 13, 2026
BIS™ Advance pEEG Module
K260907 · OLW
Covidien LP
Anesthesiology · 147d
Cleared Aug 13, 2026
Levo Gen 2 Tinnitus Therapy System
K260413 · KLW
Levo Medical Corporation
Ear, Nose, Throat · 185d
Cleared Aug 13, 2026
MIKRON TRAUMA BONE PLATE& SCREW SYSTEM
K260277 · HRS
Mikron Makina San. ve Tic. Ltd. Sti.
Orthopedic · 196d
Cleared Aug 13, 2026
Dashboard (P007000)
K260211 · MSX
Hill-Rom, Inc.
Cardiovascular · 202d
Cleared Aug 13, 2026
Any-Cem
K254201 · EMA
Mediclus Co., Ltd.
Dental · 227d
Cleared Aug 13, 2026
AIR Recon DL
K253808 · LNH
GE Medical Systems
Radiology · 258d
Cleared Aug 13, 2026
MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
K253795 · LPN
Menicon Co, Ltd.
Ophthalmic · 258d
Cleared Aug 13, 2026
High Intensity Focused Electromagnetic Stimulation Device (FE60)
K253790 · NGX
Beijing Winkonlaser Technology Limited
Physical Medicine · 258d
Cleared Aug 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor...
K253425 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 316d
Cleared Aug 12, 2026
Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
K262792 · KNW
Hologic, Inc.
General & Plastic Surgery · 6d
Cleared Aug 12, 2026
EluPro Antibiotic-Eluting BioEnvelope
K262406 · FTM
Boston Scientific
Cardiovascular · 28d
Cleared Aug 12, 2026
Millipede System
K262399 · NRY
Perfuze, Ltd.
Neurology · 29d