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
20161–20184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2020
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound...
K201012 · IYN
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Apr 30, 2020
PulsioFlex Monitoring System with ProAQT Sensor
K192169 · DXG
Pulsion Medical Systems SE
Cardiovascular · 265d
Cleared Apr 30, 2020
Biowy PICC Catheter S Kit
K192246 · LJS
Biowy Corporation
General Hospital · 255d
Cleared Apr 30, 2020
50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g...
K192290 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 251d
Cleared Apr 30, 2020
Medical Non-Ablative Fractional Laser Systems
K192350 · ONG
Wingderm Electro-Optics , Ltd.
General & Plastic Surgery · 245d
Cleared Apr 30, 2020
ArthrexVIP Web Portal
K193523 · LLZ
Arthrex, Inc.
Orthopedic · 133d
Cleared Apr 30, 2020
Turbett Instrument Pod
K200240 · FRG
Turbett Surgical, Inc.
General Hospital · 90d
Cleared Apr 30, 2020
CarboClear® II Pedicle Screw System
K200519 · NKB
CarboFix Orthopedics , Ltd.
Orthopedic · 59d
Cleared Apr 30, 2020
Biolign® Roto-Loc Cervical Plate System
K200523 · KWQ
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 59d
Cleared Apr 30, 2020
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K200816 · MAX
Spineex, Inc.
Orthopedic · 31d
Cleared Apr 30, 2020
ClickClean
K200902 · GCJ
Medeon Biodesign, Inc.
General & Plastic Surgery · 27d
Cleared Apr 29, 2020
M-Vizion Femoral Revision System Extension
K191816 · LZO
Medacta International S.A.
Orthopedic · 299d
Cleared Apr 29, 2020
GelPOINT Mini Advanced Access Platform
K191866 · GCJ
Applied Medical
General & Plastic Surgery · 292d
Cleared Apr 29, 2020
PELNAC Bilayer Wound Matrix
K191992 · KGN
Gunze Limited
General & Plastic Surgery · 279d
Cleared Apr 29, 2020
Exactech® Equinoxe® Stemless Humeral Components
K192097 · PKC
Exactech, Inc.
Orthopedic · 268d
Cleared Apr 29, 2020
da Vinci Xi Surgical System, da Vinci X Surgical System
K192803 · NAY
Intuitive Surgical
General & Plastic Surgery · 212d
Cleared Apr 29, 2020
Humeral Cup Stability & Humeral Cup 135/145o Stability
K193394 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 145d
Cleared Apr 29, 2020
Evry
K200327 · LNH
Synaptive Medical, Inc.
Radiology · 79d
Cleared Apr 29, 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K200807 · JXG
Irras USA, Inc.
Neurology · 33d
Cleared Apr 28, 2020
Magicore II System
K192197 · DZE
Innobiosurg Co., Ltd.
Dental · 259d
Cleared Apr 28, 2020
Single Use Injector
K192498 · FBK
Olympus Medical Systems Corp.
Gastroenterology & Urology · 230d
Cleared Apr 28, 2020
Vicks VNT200 No Touch Forehead Thermometer
K193213 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 159d
Cleared Apr 28, 2020
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
K193592 · DZE
Jjgc Industria E Comercio DE...
Dental · 127d
Cleared Apr 28, 2020
Hive™ Stand-alone Anterior Lumbar Interbody System
K200541 · OVD
Hd Lifesciences, LLC
Orthopedic · 56d