Search FDA 510(k) Database

7,071 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
20137–20160 of 174,061
Cleared Oct 07, 2019
Dexcom G6 Pro Continuous Glucose Monitoring System
K191833 · QII
Dexcom, Inc.
Chemistry · 90d
Cleared Oct 05, 2019
AFX Femoral Implant with Inserter
K192428 · MBI
Cayenne Medical
Orthopedic · 30d
Cleared Oct 04, 2019
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile,...
K183441 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 296d
Cleared Oct 04, 2019
Vivio System
K183710 · DQD
Avicena, LLC
Cardiovascular · 277d
Cleared Oct 04, 2019
Urethrotech UCD
K190060 · EZL
Urethrotech
Gastroenterology & Urology · 266d
Cleared Oct 04, 2019
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
K190183 · MEG
Anhui Hongyu Wuzhou Medical...
General Hospital · 245d
Cleared Oct 04, 2019
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate,...
K190298 · CDD
Beckman Coulter Biomedical GmbH
Chemistry · 235d
Cleared Oct 04, 2019
Safergel Sterile Ultrasound Gel
K190591 · MUI
Safersonic Us, Inc.
Radiology · 211d
Cleared Oct 04, 2019
Tokuyama Rebase III
K190940 · EBI
Tokuyama Dental Corporation
Dental · 177d
Cleared Oct 04, 2019
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S /...
K191713 · JAA
Omega Medical Imaging, LLC
Radiology · 100d
Cleared Oct 04, 2019
Ceramill A-Temp
K191843 · EBG
Amann Girrbach AG
Dental · 87d
Cleared Oct 04, 2019
ProFound AI Software V2.1
K191994 · QDQ
Icad, Inc.
Radiology · 70d
Cleared Oct 04, 2019
Bausch + Lomb PreVue Inserter for enVista Preloaded
K192005 · MSS
Bausch & Lomb, Inc.
Ophthalmic · 67d
Cleared Oct 04, 2019
Sutter Arrowtip Monopolar Electrodes
K192128 · GEI
Sutter Medizintechnik GmbH
General & Plastic Surgery · 58d
Cleared Oct 04, 2019
Steerable Introducer 12F
K192422 · DRA
Freudenberg Medical, LLC
Cardiovascular · 30d
Cleared Oct 04, 2019
LZI Methadone II Enzyme Immunoassay
K192433 · DJR
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Oct 04, 2019
Delta Xtend Revers Shoulder System
K192448 · PHX
Depuy(Ireland)
Orthopedic · 28d
Cleared Oct 03, 2019
ALFA GATE Dental Implants System
K182143 · DZE
Alfa Gate Mazen, Ltd.
Dental · 422d
Cleared Oct 03, 2019
Asthma Monitor AM3
K183479 · BZG
Eresearch Technology
Anesthesiology · 290d
Cleared Oct 03, 2019
SAHARA Stabilization System
K190179 · OVD
K2m, Inc.
Orthopedic · 244d
Cleared Oct 03, 2019
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
K190208 · FFX
Diversatek Healthcare
Gastroenterology & Urology · 241d
Cleared Oct 03, 2019
CD Horizon™ Astute™ Spinal System
K191066 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Oct 03, 2019
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · DKZ
Atlas Medical
Toxicology · 161d
Cleared Oct 03, 2019
XACT Robotic System
K191332 · JAK
Xact Robotics, Ltd.
Radiology · 140d