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

Filters: 2026–2026 ×
2,517 results
505–528 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Aug 12, 2026
APRO 35 Swift Catheter
K262392 · DQY
Alembic, LLC
Neurology · 29d
Cleared Aug 12, 2026
APRO 35 Swift Catheter and Alembic Aspiration Tubing
K262391 · NRY
Alembic, LLC
Neurology · 29d
Cleared Aug 12, 2026
Large Compression Screws
K262344 · HWC
TriMed, Inc.
Orthopedic · 33d
Cleared Aug 12, 2026
NeuroQuant PET
K261916 · LLZ
Cortechs Labs, Inc.
Radiology · 64d
Cleared Aug 12, 2026
BA-004CC
K261170 · ITX
Fujifilm Corporation
Radiology · 125d
Cleared Aug 12, 2026
ManaCold Compression System
K260944 · IRP
Manamed, LLC
Physical Medicine · 142d
Cleared Aug 12, 2026
CadAI-B Dx
K260086 · QDQ
BeamWorks, Inc.
Radiology · 212d
Cleared Aug 12, 2026
Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse...
K253846 · OAB
Hangzhou Ruidi Biotechnology , Ltd.
General & Plastic Surgery · 253d
Cleared Aug 12, 2026
Masimo Root Monitoring System
K253417 · MWI
Masimo Corporation
Anesthesiology · 315d
Cleared Aug 12, 2026
GF-310R Multigas Unit (GF-310R)
K251641 · CCK
Nihon Kohden Corporation
Anesthesiology · 440d
Cleared Aug 11, 2026
Stelo Glucose Biosensor System
K262472 · SBH
Dexcom, Inc.
Chemistry · 25d
Cleared Aug 11, 2026
Q Switched Nd:YAG Laser machine (QLQW-01)
K261841 · GEX
Beijing Nubway S&T Co., Ltd.
General & Plastic Surgery · 69d
Cleared Aug 11, 2026
Dexter L6 System
K261398 · SDD
Distalmotion SA
General & Plastic Surgery · 104d
Cleared Aug 11, 2026
VR® Personal Protective Level 4 Gown (VR Gowns)
K261115 · QPC
PolyConversions, Inc.
General Hospital · 130d
Cleared Aug 11, 2026
INNOVANCE® D-Dimer 2.0 (SMN 10873803)
K253985 · DAP
Siemens Healthcare Diagnostic...
Hematology · 242d
Cleared Aug 11, 2026
Vashe Plus Antimicrobial Solution
K253665 · FRO
Urgo Medical North America, LLC
General & Plastic Surgery · 263d
Cleared Aug 10, 2026
Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type...
K262427 · FMI
Hh Global Technology, Inc.
General Hospital · 25d
Cleared Aug 10, 2026
Hair Removal Device (R3C16-G Pro, R3C16-V Pro)
K261705 · OHT
Shenzhen Jianchao Intelligent...
General & Plastic Surgery · 80d
Cleared Aug 10, 2026
Eye Recovery Pro (PH-e03)
K261602 · OHS
Shenzhen Goodwind Technology...
General & Plastic Surgery · 88d