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
34513–34536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2015
NEODENT IMPLANT SYSTEM
K141777 · DZE
Jjgc Industria E Comercio DE...
Dental · 383d
Cleared Jul 20, 2015
Visi Mobile Monitoring System, Visi Mobile Chest Sensor
K142827 · MHX
Sotera Wireless, Inc.
Cardiovascular · 293d
Cleared Jul 20, 2015
Medline Natural Lubricating Liquid
K143322 · NUC
Medline Industries, Inc.
Obstetrics & Gynecology · 243d
Cleared Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
K150066 · LZO
Exactech, Inc.
Orthopedic · 188d
Cleared Jul 20, 2015
Evacore Fully Disposable Vacuum Assist Biopsy Device
K150088 · KNW
Pin-Point Care Corp.
Gastroenterology & Urology · 185d
Cleared Jul 20, 2015
Micro well group culture dish, 9-well
K150756 · MQK
Hertart
Obstetrics & Gynecology · 119d
Cleared CT Jul 20, 2015
Trojan Riviera Personal Lubricant
K150886 · NUC
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 109d
Cleared Jul 20, 2015
Caiman Seal and Cut Technology
K151696 · GEI
Aesculap, Inc.
General & Plastic Surgery · 27d
Cleared Jul 19, 2015
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · MUH
Rayence Co., Ltd.
Radiology · 25d
Cleared Jul 17, 2015
The Moses Express appliance
K142651 · LRK
Allen J. Moses, Dds, Ltd.
Dental · 302d
Cleared Jul 17, 2015
UltraLinq
K143176 · LLZ
Ultralinq Healthcare Solutions, Inc.
Radiology · 255d
Cleared Jul 17, 2015
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA...
K143687 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 205d
Cleared Jul 17, 2015
CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV,...
K150245 · CCK
GE Healthcare Finland Oy
Anesthesiology · 165d
Cleared Jul 17, 2015
Capnostream 35 Portable Respiratory Monitor
K150272 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 163d
Cleared Jul 17, 2015
ProMIS Fixation System
K150380 · NKB
Premia Spine, Ltd.
Orthopedic · 154d
Cleared CT Jul 17, 2015
Medrobotics Flex System
K150776 · EOB
Medrobotics Corporation
Ear, Nose, Throat · 115d
Cleared Jul 17, 2015
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set...
K150839 · JAQ
Varian Medical Systems, Inc.
Radiology · 109d
Cleared Jul 17, 2015
SURGISEAL Topical Skin Adhesvie
K150866 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 107d
Cleared Jul 17, 2015
INTEGO Family and Accesories
K150909 · EIA
Sirona Dental Systems GmbH
Dental · 105d
Cleared Jul 17, 2015
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External...
K151046 · PGI
Meridian Bioscience, Inc.
Microbiology · 88d
Cleared Jul 17, 2015
Lotus Series 4 Ultrasonic Surgical System & Accessories
K151101 · LFL
Sra Developments, Ltd.
General & Plastic Surgery · 84d
Cleared Jul 17, 2015
A-CIFT SoloFuse
K151198 · OVE
Spinefrontier, Inc.
Orthopedic · 73d
Cleared Jul 17, 2015
Biograph mCT and mCT Flow PET/CT Scanners
K151486 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Jul 17, 2015
Coronis Uniti
K151505 · PGY
Barco N.V.
Radiology · 43d