FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
11953–11976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2022
AEYE-DS
K221183 · PIB
Aeye Health, Inc.
Ophthalmic · 199d
Cleared Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · JLW
Beckman Coulter, Inc.
Chemistry · 196d
Cleared Nov 10, 2022
WOLF Thrombectomy™ SmartClaw Catheter
K221391 · QEW
Devoro Medical, Inc.
Cardiovascular · 181d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Fujifilm Corporation
Radiology · 154d
Cleared Nov 10, 2022
SprintRay High Impact Denture Base
K221678 · EBI
Sprintray, Inc.
Dental · 154d
Cleared Nov 10, 2022
Dental LT Clear V2 Resin
K222061 · MQC
Formlabs Ohio, Inc.
Dental · 120d
Cleared Nov 10, 2022
SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K222067 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 120d
Cleared Nov 10, 2022
Catalyst EA Convertible Stemmed Shoulder
K222317 · KWS
Catalyst Orthoscience, Inc.
Orthopedic · 100d
Cleared Nov 10, 2022
SNOR LOCK
K222475 · LRK
Solbaro Co., Ltd.
Dental · 86d
Cleared Nov 10, 2022
H1
K222504 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 84d
Cleared Nov 10, 2022
Humask Pro Vision, Humask Pro Vision 3000
K222551 · FXX
Entreprise Premont, Inc.
General Hospital · 79d
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