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
20425–20448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 2020
da Vinci X and Xi Surgical System
K183086 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 511d
Cleared Mar 31, 2020
Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis...
K191860 · KGO
Semperit Technische Produkte...
General Hospital · 264d
Cleared Mar 31, 2020
iCEWav Neuromonitoring Platform
K191868 · GWQ
Ice Neurosystems, Inc.
Neurology · 263d
Cleared Mar 31, 2020
SiteSeal Femoral Compression Device
K192413 · DXC
Ensite Vacular, LLC
Cardiovascular · 209d
Cleared Mar 31, 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818 · PML
Stryker Corporation
Orthopedic · 182d
Cleared Mar 31, 2020
Sectra Digital Pathology Module
K193054 · QKQ
Sectra AB
Pathology · 151d
Cleared Mar 31, 2020
Rapid ICH
K193087 · QAS
Ischemaview Incorporated
Radiology · 146d
Cleared Mar 31, 2020
SI-BONE iFuse Implant System®
K193524 · OUR
SI-BONE, Inc.
Orthopedic · 103d
Cleared Mar 31, 2020
CytoCore
K200278 · KNW
Praxis Medical, LLC
General & Plastic Surgery · 56d
Cleared Mar 31, 2020
The Gecko Spinal System
K200281 · OWI
Ortho Development Corporation
Orthopedic · 56d
Cleared Mar 31, 2020
Trigger Switch and Cord
K200455 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 35d
Cleared Mar 31, 2020
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K200556 · EZL
H R Pharmaceuticals, Inc.
Gastroenterology & Urology · 28d
Cleared CT Mar 31, 2020
Tablo Hemodialysis System
K200741 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 30, 2020
System 83 Plus Washer/Disinfector
K173590 · FEB
Custom Ultrasonics, Inc.
General Hospital · 860d
Cleared Mar 30, 2020
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
K192490 · GAT
Teleflex Medical
General & Plastic Surgery · 201d
Cleared Mar 30, 2020
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
K192640 · HGX
Guangzhou Yongyi Industrial Co., Ltd.
Obstetrics & Gynecology · 188d
Cleared Mar 30, 2020
T-Line Hernia Mesh
K193144 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 138d
Cleared Mar 30, 2020
Agilon Strip
K193487 · MQV
Biogennix, LLC
Orthopedic · 104d
Cleared Mar 30, 2020
NuVasive Cohere Thoracolumbar Interbody System
K193541 · MAX
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Mar 30, 2020
Universal Base Conical Connection (CC)
K200040 · NHA
Nobel Biocare AG
Dental · 82d
Cleared Mar 29, 2020
Torc Body
K192039 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 243d
Cleared Mar 29, 2020
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE...
K200494 · MHX
Ge Healthcare
Cardiovascular · 30d
Cleared Mar 29, 2020
QuickDraw Venous Cannula
K200499 · DWF
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Mar 28, 2020
MRI ECG Patient Cable
K192852 · LNH
Ivy Biomedical Systems, Inc.
Cardiovascular · 177d