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
18289–18312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 28, 2020
Smart SPACE Shoulder System
K202454 · QHE
Techmah Medical, LLC
Orthopedic · 123d
Cleared Dec 28, 2020
Quadra-P
K202730 · LZO
Medacta International S.A.
Orthopedic · 101d
Cleared Dec 28, 2020
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K203062 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 80d
Cleared Dec 27, 2020
MBT Sepsityper
K193419 · QNJ
Bruker Daltonik GmbH
Microbiology · 384d
Cleared Dec 27, 2020
8-CH Electroencephalography Amplifier
K201747 · GWL
Hipposcreen Neurotech Corp.
Neurology · 184d
Cleared Dec 25, 2020
ImPACT Version 4
K202485 · POM
Impact Applications, Inc.
Neurology · 116d
Cleared Dec 24, 2020
Image Quality Analyzer (IQA)
K200422 · NFJ
Visionquest Biomedical, Inc.
Ophthalmic · 308d
Cleared Dec 24, 2020
Acute Dual Lumen Hemodialysis Catheter
K200426 · MPB
Health Line International Corporation
Gastroenterology & Urology · 307d
Cleared Dec 24, 2020
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and...
K203544 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 20d
Cleared Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
K192073 · PTA
Helix Opco, LLC
Immunology · 509d
Cleared Dec 23, 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K193670 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 358d
Cleared Dec 23, 2020
Customized Contour Implant
K200610 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 289d
Cleared Dec 23, 2020
DeRoyal Temperature Monitoring Probe
K200631 · FLL
Deroyal Industries, Inc.
General Hospital · 288d
Cleared Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE...
K200697 · GXH
AtriCure, Inc.
Neurology · 281d
Cleared Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
K201458 · GZJ
Delta International Services &...
Neurology · 205d
Cleared Dec 23, 2020
Plasdent Disposable Barrier Sleeves and Barrier Film
K201604 · PEM
Plasdent Corporation
General & Plastic Surgery · 191d
Cleared Dec 23, 2020
Medical Face mask
K202061 · FXX
Jiangsu Province Jianerkang Medical...
General Hospital · 149d
Cleared Dec 23, 2020
Locking device
K202237 · ODC
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 138d
Cleared Dec 23, 2020
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal,...
K202320 · OLO
Brainlab AG
Orthopedic · 128d
Cleared Dec 23, 2020
SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
K202353 · IZL
Shantou Institute of Ultrasonic...
Radiology · 127d
Cleared Dec 23, 2020
ControlRad Select Model Z
K202431 · OWB
Controlrad, Inc.
Radiology · 120d
Cleared Dec 23, 2020
OmniTom Elite
K202526 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 113d
Cleared Dec 23, 2020
F3D Corpectomy System
K202637 · MQP
Corelink, LLC
Orthopedic · 103d
Cleared Dec 23, 2020
Affinity
K202882 · KPS
Hermes Medical Solutions AB
Radiology · 86d