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
22249–22272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2019
Libertas – Taper Uncemented Femoral Stem
K183684 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 238d
Cleared Aug 23, 2019
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
K190127 · NLH
Innovative Health, LLC
Cardiovascular · 207d
Cleared Aug 23, 2019
Hemoflow F3 and F4 Dialyzers
K190459 · FJI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 178d
Cleared Aug 23, 2019
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
K190593 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 169d
Cleared Aug 23, 2019
CrossBay Cervical Dilator Catheter System
K190813 · PON
Crossbay Medical
Obstetrics & Gynecology · 147d
Cleared Aug 23, 2019
1-Step Culture Medium
K191063 · MQL
Shenzhen Vitavitro Biotech Co., Ltd.
Obstetrics & Gynecology · 123d
Cleared Aug 23, 2019
EkoSonic Endovascular Device
K191119 · QEY
Btg International, Inc.
Cardiovascular · 119d
Cleared Aug 23, 2019
Customized Contour Implant
K191130 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 116d
Cleared Aug 23, 2019
LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi,...
K191177 · GCJ
Smith and Nephew, Inc.
General & Plastic Surgery · 113d
Cleared Aug 23, 2019
Electronic Blood Pressure Monitor
K191180 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 113d
Cleared Aug 23, 2019
VariAx 2 System, VariAx 2 Mini Fragment System
K191412 · HRS
Stryker GmbH
Orthopedic · 87d
Cleared Aug 23, 2019
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
K191809 · JWY
Liofilchem S. R. L.
Microbiology · 49d
Cleared Aug 23, 2019
REMEDY Acetabular Cup
K191981 · KWL
Osteoremedies, LLC
Orthopedic · 30d
Cleared Aug 23, 2019
OSW Aligner System
K191990 · NXC
Osw Manufacturing, LLC
Dental · 29d
Cleared Aug 23, 2019
Rampart™ One Lumbar Interbody Fusion System
K192047 · OVD
Spineology, Inc.
Orthopedic · 23d
Cleared Aug 22, 2019
Osstell Beacon
K181888 · EKX
Osstell AB
Dental · 405d
Cleared Aug 22, 2019
Bendit2.7 Steerable Microcatheter
K190126 · DQO
Bend IT Technologies, Ltd.
Cardiovascular · 206d
Cleared Aug 22, 2019
Triathlon Total Knee System-Additional Components
K190402 · JWH
Stryker Orthopaedics (Aka Howmedica...
Orthopedic · 184d
Cleared Aug 22, 2019
BB-613WP
K190792 · DQA
Biobeat Technologies , Ltd.
Cardiovascular · 148d
Cleared Aug 22, 2019
HEALIX ADVANCE SP BIOCOMPOSITE Anchor
K191242 · MAI
Medos International SARL
Orthopedic · 105d
Cleared Aug 22, 2019
INFINITY Total Ankle System, INBONE Total Ankle System
K191393 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 22, 2019
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
K191953 · JWY
Biomerieux S.A.
Microbiology · 31d
Cleared Aug 22, 2019
NCB Polyaxial Locking Plate System
K192021 · HRS
Zimmer GmbH
Orthopedic · 24d
Cleared Aug 21, 2019
QNext and DG-PT
K183390 · JPA
Diagnostic Grifols, S.A.
Hematology · 258d