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
8065–8088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2023
VersaCross Connect™ Transseptal Dilator
K233647 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 30d
Cleared Dec 14, 2023
Secret Pro
K233374 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 73d
Cleared Dec 14, 2023
VELYS™ Robotic-Assisted Solution
K233227 · OLO
Depuy Ireland UC
Orthopedic · 77d
Cleared Dec 14, 2023
Vial Adapter 20mm
K232875 · LHI
West Pharma Services Il, Ltd.
General Hospital · 90d
Cleared Dec 14, 2023
Disposable Endobronchial Blocker Tube
K232580 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 111d
Cleared Dec 14, 2023
SofWave System
K232455 · OHV
Sofwave Medical, Ltd.
Physical Medicine · 122d
Cleared Dec 14, 2023
Disposable Veress Needles
K232401 · HIF
Hangzhou Kangji Medical Instrument...
Obstetrics & Gynecology · 126d
Cleared Dec 14, 2023
PhySoftAMS®
K232283 · MQS
Physician Software Systems, LLC
Gastroenterology & Urology · 136d
Cleared Dec 14, 2023
ARIX Ankle Distal Tibia System
K231887 · HRS
Jeil Medical Corporation
Orthopedic · 170d
Cleared Dec 14, 2023
MedHealth DVT compression Devices MHH900S/MHH900E
K231801 · JOW
Medhealth Medical Limited
Cardiovascular · 177d
Cleared Dec 14, 2023
Disposable Hot Biopsy Forceps
K231721 · KGE
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 184d
Cleared Dec 14, 2023
PherDal® At-Home Insemination Kit
K231645 · QYZ
Pherdal Fertility Science, Inc.
Obstetrics & Gynecology · 192d
Cleared Dec 14, 2023
StrokeViewer Perfusion
K231570 · LLZ
Nico-Lab B.V.
Radiology · 197d
Cleared Dec 14, 2023
bright CT
K231181 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 232d
Cleared Dec 14, 2023
ARTIS icono (VE30A)
K230950 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 254d
Cleared Dec 14, 2023
C50
K223470 · NBL
Sopro
Dental · 392d
Cleared Dec 13, 2023
DT Controlled Phototherapy Equipment
K233811 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 14d
Cleared Dec 13, 2023
Sofia 2 SARS Antigen+ FIA
K233688 · QVF
Quidel Corporation
Microbiology · 26d
Cleared Dec 13, 2023
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · CFN
Siemens Healthcare Diagnostics...
Immunology · 28d
Cleared Dec 13, 2023
NeuroStar Advanced Therapy System (Version 3.8)
K233621 · OBP
Neuronetics
Neurology · 30d
Cleared Dec 13, 2023
Genesys Spine 3DP AIS-C II Cervical Interbody System
K233594 · OVE
Genesys Spine
Orthopedic · 35d
Cleared Dec 13, 2023
AllTest Multi-Drug Rapid Test Cup
K233019 · DKZ
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 82d
Cleared Dec 13, 2023
FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex...
K232877 · MRW
K&J Consulting Corporation
Orthopedic · 89d
Cleared Dec 13, 2023
Radiant Renewal Skincare Wand (HD-15, HD-15A)
K232863 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 89d