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
29113–29136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 2017
Tyber Medical Wedge System
K171327 · PLF
Tyber Medical, LLC
Orthopedic · 11d
Cleared CT May 15, 2017
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
K153410 · SEL
3M Company
General & Plastic Surgery · 537d
Cleared May 15, 2017
SS SA Fixture
K163557 · DZE
Osstem Implant Co., Ltd.
Dental · 147d
Cleared May 15, 2017
Dental 5 Multi Diode laser
K163638 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 143d
Cleared May 15, 2017
SPiN Thoracic Navigation System
K170023 · JAK
Veran Medical Technologies, Inc.
Radiology · 132d
Cleared May 15, 2017
IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece,...
K170312 · HBC
Medtronic Powered Surgical Solutions
Neurology · 103d
Cleared CT May 15, 2017
ULTRASHAPE POWER SYSTEM
K170370 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 98d
Cleared May 15, 2017
PNEUMOCLEAR
K170784 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 61d
Cleared May 15, 2017
EVS 2430W, EVS 2430GW
K171137 · MQB
DRTECH Corporation
Radiology · 28d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · KHE
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
Cleared May 12, 2017
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems...
K161261 · MQL
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 373d
Cleared May 12, 2017
Avazzia
K162392 · NUH
Avazzia, Inc.
Neurology · 259d
Cleared May 12, 2017
Unity Network ID
K170199 · MWI
Ge Healthcare
Cardiovascular · 109d
Cleared May 12, 2017
Belimed Steam Sterilizer MST-H TOP 5000
K170228 · FLE
Belimed AG
General Hospital · 107d
Cleared May 12, 2017
Piccolo Composite® Plate System
K170401 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 92d
Cleared May 12, 2017
N Latex Cystatin C
K171072 · NDY
Siemens Healthcare Diagnostics...
Chemistry · 32d
Cleared May 12, 2017
iChemVELOCITY Automated Urine Chemistry System
K171083 · JIL
Iris Diagnostics, A Division of Iris...
Chemistry · 31d
Cleared May 12, 2017
GM85
K171119 · IZL
Samsung Electronics Co., Ltd.
Radiology · 28d
Cleared May 11, 2017
Anybattery C2 Rechargeable Battery
K160667 · DPS
Anybattery, Inc.
Cardiovascular · 428d
Cleared May 11, 2017
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 300d
Cleared May 11, 2017
UniTex Non-Sterile, Powder-Free, Latex Examination Glove
K161961 · LYY
Ug Global Resources Sdn. Bhd.
General Hospital · 297d
Cleared May 11, 2017
Winner Transfer Wheelchair
K162328 · IOR
Winner SG Pte, Ltd.
Physical Medicine · 265d
Cleared May 11, 2017
AIK Sterile Acupuncture Needles for Single Use
K162566 · MQX
Changchun Aik Medical Devices Co., Ltd.
General Hospital · 239d
Cleared May 11, 2017
Kitazato IUI Catheter
K162667 · MQF
Kitazato Corporation
Obstetrics & Gynecology · 227d