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
11689–11712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2022
Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx
K222667 · NFT
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 65d
Cleared Nov 10, 2022
AquaPulse® Irrigation Tubing
K223171 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 30d
Cleared Nov 10, 2022
BreathID® Smart System
K223185 · MSQ
Meridian Bioscience Israel , Ltd.
Microbiology · 29d
Cleared Nov 10, 2022
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
K223198 · MHC
Bard Access Systems
General Hospital · 28d
Cleared Nov 09, 2022
Eonis SCID-SMA kit
K203035 · PJI
Perkinelmer, Inc.
Medical Genetics · 765d
Cleared Nov 09, 2022
MONET Anterior Cervical Plate System
K220334 · KWQ
Ctl Medical Corporation
Orthopedic · 278d
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