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
3049–3072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2025
Baby Gorilla®/Gorilla® Plating System
K250952 · HRS
Paragon 28, Inc.
Orthopedic · 112d
Cleared Jul 18, 2025
HeartFlow Analysis
K250902 · PJA
HeartFlow, Inc.
Radiology · 114d
Cleared Jul 18, 2025
INNOVISION-P5
K250750 · IZL
Dk Medical Systems Co., Ltd.
Radiology · 128d
Cleared Jul 18, 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · OBO
Tomey Corporation
Ophthalmic · 143d
Cleared Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64...
K250084 · LTT
Beckman Coulter, Inc.
Microbiology · 186d
Cleared Jul 18, 2025
True Non-Surgical Spinal Decompression System (DRX9000-SL)
K243775 · ITH
Excite Medical of Tampa Bay, LLC
Physical Medicine · 221d
Cleared Jul 18, 2025
HyHub™ and HyHub™ Duo Vial Access Devices
K243404 · LHI
Takeda Pharmaceuticals
General Hospital · 259d
Cleared Jul 18, 2025
ELEC ENGINE (Model: ISE-170L)
K231562 · EBW
Micro-Nx Co., Ltd.
Dental · 779d
Cleared Jul 17, 2025
uMI Panvivo (uMI Panvivo)
K251839 · KPS
Shanghai United Imaging Healthcare...
Radiology · 31d
Cleared Jul 17, 2025
Device 300423 Granules
K251556 · MQV
Geistlich Pharma AG
Orthopedic · 57d
Cleared Jul 17, 2025
K5 Cart, K5 Mount, K5 Swing
K251491 · EIA
Osstem Implant Company., Ltd. Chair...
Dental · 64d
Cleared Jul 17, 2025
VersaWrap Nerve Protector (VTP-2201)
K251175 · JXI
Alafair Biosciences
Neurology · 92d
Cleared Jul 17, 2025
MectaLIF 3D Metal
K251016 · MAX
Medacta International S.A.
Orthopedic · 106d
Cleared Jul 17, 2025
DualView Catheter
K250751 · DQO
Terumo Corporation
Cardiovascular · 127d
Cleared Jul 17, 2025
0.014” Willow Guidewire
K243756 · MOF
Arbor Endovascular, LLC
Neurology · 223d
Cleared Jul 17, 2025
uMR Ultra
K243547 · LNH
Shanghai United Imaging Healthcare...
Radiology · 244d
Cleared Jul 17, 2025
e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G...
K243428 · MOS
Dxtx Medical, Inc.
Radiology · 254d
Cleared Jul 17, 2025
HESTIA
K243420 · MUE
Genoray Co., Ltd.
Radiology · 255d
Cleared Jul 17, 2025
Masimo O3 Regional Oximeter
K243324 · MUD
Masimo Corporation
General & Plastic Surgery · 267d
Cleared Jul 17, 2025
Elecsys Cortisol III
K242505 · JFT
Roche Diagnostics
Chemistry · 329d
Cleared Jul 16, 2025
Marigen Wound Extra
K251845 · KGN
Kerecis Limited
General & Plastic Surgery · 30d
Cleared Jul 16, 2025
EchoPAC Software Only / EchoPAC Plug-in
K251342 · QIH
GE Medical Systems Ultrasound and...
Radiology · 77d
Cleared Jul 16, 2025
da Vinci Surgical System (IS5000)
K251202 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 16, 2025
HyperVue™ Software
K251198 · NQQ
Spectrawave, Inc.
Cardiovascular · 90d