FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
23737–23760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2019
Dexcom G6 Continuous Glucose Monitoring System
K183206 · QBJ
Dexcom, Inc.
Chemistry · 87d
Cleared Feb 14, 2019
MAGNETOM Amira, MAGNETOM Sempra
K183221 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Feb 14, 2019
AdvantageRib System
K183317 · HRS
Sig Medical Corporation
Orthopedic · 76d
Cleared Feb 14, 2019
HEALIX ADVANCE Anchor with DYNACORD Suture
K183506 · MAI
Medos International SARL
Orthopedic · 58d
Cleared Feb 14, 2019
DD cube ONE ML
K183569 · EIH
Dental Direkt GmbH
Dental · 55d
Cleared Feb 14, 2019
PhotoFix Decellularized Bovine Pericardium
K183635 · PSQ
Cryolife, Inc.
Cardiovascular · 50d
Cleared Feb 14, 2019
Presero 3D Scanning System
K190074 · LLZ
Certis Health
General & Plastic Surgery · 29d
Cleared Feb 13, 2019
U&U Blood Collection Sets
K181508 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 251d
Cleared Feb 13, 2019
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
K181661 · OYX
Bio-Rad Laboratories, Inc.
Medical Genetics · 233d
Cleared Feb 13, 2019
Kava and Kava with Herbst
K182661 · LRK
Sketchpad Innovations, LLC
Dental · 141d
Cleared Feb 13, 2019
Fenom Pro Nitric Oxide Test
K182874 · MXA
Spirosure, Inc.
Chemistry · 124d
Cleared CT Feb 13, 2019
ENvizion Medical ENvue
K182915 · KNT
Envizion Medical , Ltd.
Gastroenterology & Urology · 118d
Cleared Feb 13, 2019
NuVasive Reline System
K182974 · NKB
Nu Vasive, Incorporated
Orthopedic · 110d
Cleared Feb 13, 2019
EPIC Extremity Fusion Plate System
K182991 · HRS
Epic Extremity, LLC
Orthopedic · 107d
Cleared Feb 13, 2019
SnapShot Freeze 2
K183161 · JAK
Ge Medical Systems, LLC
Radiology · 90d
Cleared Feb 12, 2019
WiEMSpro
K181955 · NGX
Medical Cables S.L.
Physical Medicine · 204d
Cleared Feb 12, 2019
FORA P100 Blood Pressure Monitoring System
K182934 · DXN
Taidoc Technology Corporation
Cardiovascular · 113d
Cleared Feb 12, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam...
K183127 · LTT
Beckman Coulter, Inc.
Microbiology · 91d
Cleared Feb 12, 2019
Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens
K183167 · HQD
Bausch & Lomb, Incorporated
Ophthalmic · 89d
Cleared Feb 12, 2019
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium...
K183375 · JJE
Horiba, Ltd.
Chemistry · 68d
Cleared Feb 12, 2019
Cruxcan (CRX-1000)
K183637 · MUH
Cruxell Corp.
Radiology · 48d
Cleared Feb 12, 2019
KOWA VK-2s
K190056 · NFJ
Kowa Co. Ltd. Chofu
Ophthalmic · 32d
Cleared Feb 12, 2019
Aurora Evacuator
K190075 · GEI
Rebound Therapeutics
General & Plastic Surgery · 27d
Cleared Feb 11, 2019
TrueDorsal Devices
K180691 · LRK
True Function Laboratory, Inc.
Dental · 332d