Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
31993–32016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2016
Acclarix AX8 Diagnostic Ultrasound System
K161300 · IYO
Edan Instruments, Inc.
Radiology · 22d
Cleared May 27, 2016
O-PEP
K150044 · BWF
Pari Respiratory Equipment, Inc.
Anesthesiology · 501d
Cleared May 27, 2016
Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
K151781 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 331d
Cleared May 27, 2016
BIJOU Orthodontic Ceramic Bracket
K152167 · NJM
World Bio Tech Co., Ltd.
Dental · 297d
Cleared May 27, 2016
Glocyte Automated Cell Counter System
K152776 · GKL
Advanced Instruments, Inc.
Hematology · 245d
Cleared May 27, 2016
NoCord
K152826 · ELW
Centrix, Inc.
Dental · 241d
Cleared May 27, 2016
Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333,...
K153149 · FLL
Sejoy Electronics & Instruments Co.,...
General Hospital · 210d
Cleared May 27, 2016
3mensio Workstation
K153736 · LLZ
Pie Medical Imaging BV
Radiology · 151d
Cleared May 27, 2016
neoBLUE® LED Phototherapy System
K160305 · LBI
Natus Medical Incorporated
General Hospital · 113d
Cleared May 27, 2016
BD Eclipse Hypodermic Needle
K161170 · FMI
Becton, Dickinson and Company
General Hospital · 31d
Cleared May 26, 2016
MC BIO Supertack Tack 3mm, 4mm and 5mm
K151540 · DZL
Eli-Ka Technologies
Dental · 353d
Cleared May 26, 2016
Auris Robotic Endoscopy System (ARES)
K152319 · EOQ
Auris Surgical Robotics, Inc.
Ear, Nose, Throat · 283d
Cleared May 26, 2016
ORAcollect.Dx
K152464 · OYJ
DNA Genotek, Inc.
Chemistry · 269d
Cleared May 26, 2016
Z5 Slit lamp microscope, Z2 Slit lamp microscope
K152535 · HJO
Takagi Seiko Co., Ltd.
Ophthalmic · 265d
Cleared May 26, 2016
Oragene Dx
K152556 · OYJ
DNA Genotek, Inc.
Chemistry · 261d
Cleared May 26, 2016
Stivax
K152571 · BWK
Biegler GmbH
Neurology · 260d
Cleared May 26, 2016
eSensor Warfarin Sensitivity Saliva Test
K152612 · ODW
Genmark Diagnostics, Incorporated
Chemistry · 255d
Cleared May 26, 2016
Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves
K152818 · LYZ
Ideal Plastic Co., Ltd.
General Hospital · 241d
Cleared May 26, 2016
AxSOS 3Ti
K153379 · HRS
Stryker GmbH
Orthopedic · 185d
Cleared CT May 26, 2016
Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy...
K160344 · LPL
Visco Vision, Inc.
Ophthalmic · 108d
Cleared May 26, 2016
AdTec
K160393 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 105d
Cleared May 26, 2016
Noxilizer Surgical Ruler
K160501 · FTY
Noxilizer, Inc.
General & Plastic Surgery · 93d
Cleared May 26, 2016
Stealth-Midas System
K160713 · OLO
Medtronic Powered Surgical Solutions
Orthopedic · 72d
Cleared May 26, 2016
Reveal LINQ
K160809 · MXD
Medtronic, Inc.
Cardiovascular · 63d