Search FDA 510(k) Database

6,607 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
10801–10824 of 174,061
Cleared Nov 09, 2022
GammaTile
K221539 · KXK
Gt Medical Technologies
Radiology · 166d
Cleared Nov 09, 2022
Universal CMF System
K221855 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 135d
Cleared Nov 09, 2022
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K222162 · FAJ
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 111d
Cleared Nov 09, 2022
SOLIX
K222166 · OBO
Optovue, Inc.
Ophthalmic · 111d
Cleared Nov 09, 2022
Exo Iris (El2001)
K222198 · IYN
Exo Imaging, Inc.
Radiology · 110d
Cleared Nov 09, 2022
Zaga Zygomatic System
K222497 · DZE
Southern Implants (Pty), Ltd.
Dental · 83d
Cleared Nov 09, 2022
ViewMate Multi Ultrasound System
K222754 · IYN
Shenzhen Mindray Bio-Meidcal...
Radiology · 58d
Cleared Nov 09, 2022
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
K223132 · HQF
Iridex Corporation
Ophthalmic · 37d
Cleared Nov 08, 2022
Oxyfit Pulse Oximeter
K203812 · DQA
Shenzhen Viatom Technology Co., Ltd.
Anesthesiology · 680d
Cleared Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
K210346 · GKZ
Sysmex America, Inc.
Hematology · 638d
Cleared Nov 08, 2022
EFAI ChestSuite XR Pneumothorax Assessment System
K221552 · QFM
Ever Fortune.Ai, Co., Ltd.
Radiology · 161d
Cleared Nov 08, 2022
Hisense LCD monitor HMD2G21S, HMD3G21S
K222132 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 112d
Cleared Nov 08, 2022
Sonata Transcervical Fibroid Ablation System 2.2
K222304 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 99d
Cleared Nov 08, 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · OCX
Diversatek Healthcare
Gastroenterology & Urology · 60d
Cleared Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · DQY
Medtronic
Cardiovascular · 28d
Cleared Nov 07, 2022
Eclipse MINI Model 98900
K212317 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 469d
Cleared Nov 07, 2022
Lotus Prophy Angle
K220346 · EGS
Ajk Engineering, Inc.
Dental · 273d
Cleared Nov 07, 2022
Durex Patronus CloseFit, Durex Patronus Regular
K220489 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 258d
Cleared Nov 07, 2022
Smooth Drive contra angle and straight handpieces
K220874 · EGS
Lares Research
Dental · 227d
Cleared Nov 07, 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
K221833 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 137d
Cleared Nov 07, 2022
Vericor Support Catheter
K222679 · KRA
Vascupatent Medical (Shenzhen) Co., Ltd.
Cardiovascular · 62d
Cleared Nov 07, 2022
WaveForm A Interbody System
K222732 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 59d
Cleared Nov 07, 2022
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty...
K222741 · ELW
Hdi, Inc.
Dental · 59d
Cleared Nov 07, 2022
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M,...
K222800 · GEX
Sanhe Laserconn Tech Co., Ltd.
General & Plastic Surgery · 52d