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
18433–18456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2020
TENS & PMS
K201354 · NGX
Hong Qiangxing (Shenzhen) Electronics...
Physical Medicine · 204d
Cleared Dec 11, 2020
Hamilton-C6
K201658 · CBK
Hamilton Medical AG
Anesthesiology · 176d
Cleared Dec 11, 2020
CorPath GRX System
K202275 · DXX
Corindus, Inc.
Cardiovascular · 122d
Cleared Dec 11, 2020
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
K202471 · DSY
Peca Labs
Cardiovascular · 105d
Cleared Dec 11, 2020
GMK Total Knee System - TiNbN Coating
K202684 · JWH
Medacta International S.A.
Orthopedic · 87d
Cleared Dec 11, 2020
ELEOS Limb Salvage System featuring BIOGRIP
K203090 · JDI
Onkos Surgical
Orthopedic · 59d
Cleared Dec 11, 2020
3M Comply Hydrogen Peroxide Chemical Indicator 1248
K203458 · JOJ
3M Company
General Hospital · 17d
Cleared Dec 11, 2020
Drakon and Sequre Microcatheters
K203487 · DQO
Accurate Medical Therapeutics, Ltd.
Cardiovascular · 14d
Cleared Dec 10, 2020
Zimmer Segmental System
K192798 · KRO
Zimmer, Inc.
Orthopedic · 437d
Cleared CT Dec 10, 2020
Posterior Fusion Plate, HA Posterior Fusion Plate
K200066 · PEK
Spinal Simplicity, LLC
Orthopedic · 332d
Cleared Dec 10, 2020
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral...
K200376 · OLO
Navbit Pty, Ltd.
Orthopedic · 296d
Cleared Dec 10, 2020
PROFEMUR® GLADIATOR® Cemented Classic Stem
K201519 · JDI
Microport Orthopedics, Inc.
Orthopedic · 185d
Cleared Dec 10, 2020
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
K201745 · JAK
Ge Medical Systems, LLC
Radiology · 167d
Cleared Dec 10, 2020
JADE
K202231 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 125d
Cleared Dec 10, 2020
Neuronaute
K202334 · GWQ
Bioserenity Sas
Neurology · 115d
Cleared Dec 10, 2020
AquaPulse Irrigation Tubing
K202560 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 97d
Cleared Dec 10, 2020
MY01 Continuous Compartmental Pressure Monitor
K202635 · LXC
MY01, Inc.
Orthopedic · 90d
Cleared Dec 10, 2020
X-cera Pre-shaded Zirconia Blanks
K202673 · EIH
Dongguan Xiangtong Co., Ltd.
Dental · 86d
Cleared Dec 10, 2020
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
K202834 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 76d
Cleared Dec 10, 2020
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
K203042 · JAK
Canon Medical Systems Corporation
Radiology · 65d
Cleared Dec 10, 2020
3M Comply Hydrogen Peroxide Indicator Tape 1228
K203285 · JOJ
3M Company
General Hospital · 31d
Cleared Dec 10, 2020
Triever20 Curve Catheter
K203333 · QEW
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Dec 09, 2020
Infrared Body Thermometer
K200781 · FLL
Heitaida Technology Co., Ltd.
General Hospital · 273d
Cleared Dec 09, 2020
Mini Spike Plus 6/8R
K201469 · LHI
B.Braun Medical, Inc.
General Hospital · 189d