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
505–528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 10, 2026
Icona Hip Stem
K261576 · MEH
Corin, Ltd.
Orthopedic · 90d
Cleared Aug 10, 2026
Mobility Scooter (W3483, W3483A)
K260176 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 201d
Cleared Aug 10, 2026
Unimpregnated Central Venous Catheter
K260165 · FOZ
Spectrum Vascular
General Hospital · 202d
Cleared Aug 10, 2026
Mobility Scooter (W3465, W3902 (S50 Carbon))
K260094 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 209d
Cleared Aug 10, 2026
EM-TECH Passive Ultrasound Probe Strap
K254143 · ITX
EM-TECH Solutions, Inc.
Radiology · 231d