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
5017–5040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2024
Infrascanner Model 2500 (Model 2500)
K241389 · OPT
Infrascan, Inc.
Neurology · 211d
Cleared Dec 12, 2024
Aqua Medical RF Vapor Ablation System
K241271 · KNS
Aqua Medical, Inc.
Gastroenterology & Urology · 220d
Cleared Dec 12, 2024
Medicon Epiplating System
K241253 · FZE
Cmf Medicon Surgical, Inc.
General & Plastic Surgery · 223d
Cleared Dec 12, 2024
visio.lign color, visio.lign shield
K240735 · EBD
Bredent GmbH & Co. KG
Dental · 269d
Cleared Dec 12, 2024
GENIOVA aligners
K233152 · NXC
Geniova Technologies Sociedad Limitada
Dental · 442d
Cleared Dec 11, 2024
BriefCase-Triage
K243548 · QFM
Aidoc Medical , Ltd.
Radiology · 26d
Cleared Dec 11, 2024
Alinity c Benzodiazepines Reagent Kit
K243498 · JXM
Microgenics Corporation
Toxicology · 29d
Cleared Dec 11, 2024
SternalPlate Expansion
K243491 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 29d
Cleared Dec 11, 2024
Cervical Plating System
K243369 · KWQ
Life Spine, Inc.
Orthopedic · 42d
Cleared Dec 11, 2024
FAQ™ (302)
K242747 · OAP
Foreo, Inc.
General & Plastic Surgery · 90d
Cleared Dec 11, 2024
VECTR – Video Endoscopic Carpal Tunnel Release System
K242417 · HRX
Rafael Medical Devices, LLC
Orthopedic · 118d
Cleared Dec 11, 2024
Eclipse Treatment Planning System (18.1)
K242378 · MUJ
Varian Medical Systems
Radiology · 124d
Cleared Dec 11, 2024
TECHFIT DISRP® System
K242263 · DZJ
Techfit Digital Surgery, Inc.
Dental · 132d
Cleared Dec 11, 2024
Access25™ Delivery Microcatheter
K242033 · QJP
Penumbra, Inc.
Neurology · 153d
Cleared Dec 11, 2024
OsseoFit Stemless Shoulder System
K241873 · PKC
Zimmer, Inc.
Orthopedic · 167d
Cleared Dec 11, 2024
FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker...
K241219 · OWX
ZuriMED Technologies AG
Orthopedic · 224d
Cleared Dec 11, 2024
EndoTool IV (3.1)
K241088 · NDC
Monarch Medical Technologies
Chemistry · 236d
Cleared Dec 11, 2024
Disposable Subdermal Needle Electrode, Corkscrew
K241045 · GXZ
Technomed Europe
Neurology · 238d
Cleared Dec 11, 2024
Radiofrequency Generator System, Cura RF Electrode
K240758 · GEI
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 266d
Cleared Dec 10, 2024
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
K243216 · MWI
Analog Devices
Cardiovascular · 68d
Cleared Dec 10, 2024
Digital Color Doppler Ultrasound Imaging System (Readius L15)
K243132 · IYN
Shantou Institute of Ultrasonic...
Radiology · 71d
Cleared Dec 10, 2024
Philips IntelliSite Pathology Solution 5.1
K242848 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 81d
Cleared Dec 10, 2024
Aerin Console
K242630 · GEI
Aerin Medical, Inc.
General & Plastic Surgery · 98d
Cleared Dec 10, 2024
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...
K242511 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d