FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
11497–11520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2022
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · OLT
Neurosoft , Ltd.
Neurology · 303d
Cleared Nov 30, 2022
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested...
K221082 · LZA
Rhino Health, Inc.
General Hospital · 231d
Cleared Nov 30, 2022
EEA Circular Stapler with Tri-Staple Technology
K221771 · GDW
Covidien
General & Plastic Surgery · 162d
Cleared Nov 30, 2022
Elos Accurate Customized Abutment
K222044 · NHA
Elos Medtech Pinol A/S
Dental · 142d
Cleared Nov 30, 2022
Steripath Micro Blood Collection System
K222299 · JKA
Magnolia Medical Technologies
General Hospital · 121d
Cleared Nov 30, 2022
MissLan™ Digital Pregnancy Rapid Test
K222305 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 121d
Cleared Nov 30, 2022
Lancing System, Sterile Lancet for Single Use, Lancing Device
K222472 · QRL
Shandong Lianfa Medical Plastic...
General & Plastic Surgery · 106d
Cleared Nov 30, 2022
Purgo
K223328 · FRA
Aeroclean Technologies, Inc.
General Hospital · 30d
Cleared Nov 29, 2022
QStat Cartridge
K213917 · QFR
Hemosonics, LLC
Hematology · 349d
Cleared Nov 29, 2022
SmartSurgN Visualization System
K213943 · OWN
Smartsurgn Incorporated
General & Plastic Surgery · 347d
Cleared Nov 29, 2022
Disposable Safety Lancet
K222408 · FMK
Beijing Ruicheng Medical Supplies...
General & Plastic Surgery · 111d
Cleared Nov 29, 2022
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
K222641 · GDW
Covidien
General & Plastic Surgery · 89d
Cleared Nov 28, 2022
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
K211050 · FLL
Jkh Health Co., Ltd.
General Hospital · 599d
Cleared Nov 28, 2022
TorchTM Software
K220630 · LLZ
Voximetry, Incorporated
Radiology · 269d
Cleared Nov 28, 2022
pNOVUS 21 Microcatheter
K221279 · DQO
Phenox, Ltd.
Neurology · 209d
Cleared Nov 28, 2022
T-Line Hernia Mesh
K221556 · FTL
Deep Blue Medical Advances, Inc.
General & Plastic Surgery · 181d
Cleared Nov 28, 2022
Aevumed PHANTOM™-LP Suture Anchors
K222363 · MBI
Aevumed, Inc.
Orthopedic · 116d
Cleared Nov 28, 2022
Male Latex Condoms
K222611 · HIS
Suzhou Colour-Way New Material Co., Ltd.
Obstetrics & Gynecology · 90d
Cleared Nov 28, 2022
Aneroid Sphygmomanometer
K222652 · DXQ
Cardicare Company, Ltd.
Cardiovascular · 88d
Cleared Nov 28, 2022
da Vinci E-200 Electrosurgical Generator
K223039 · GEI
Intuitive Surgical
General & Plastic Surgery · 60d
Cleared Nov 28, 2022
Facet Manatee Reusable Lancing Base
K223099 · QRL
Facet Technologies, LLC
General & Plastic Surgery · 59d
Cleared Nov 28, 2022
Momentum® MIS Posterior Spinal Fixation System
K223274 · NKB
Ulrich Medical USA
Orthopedic · 35d
Cleared Nov 27, 2022
Wireless/Wired X-Ray Flat Panel Detectors
K223009 · MQB
Allengers Medical Systems Limited
Radiology · 59d
Cleared Nov 25, 2022
VSI HoloMedicine
K213215 · LLZ
Apoqlar GmbH
Radiology · 422d