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
7777–7800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2024
Minuteman G5 MIS Fusion Plate
K234051 · PEK
Spinal Simplicity, LLC
Orthopedic · 28d
Cleared Jan 18, 2024
TriMed Threaded Intramedullary Nail System
K234040 · HWC
TriMed, Inc.
Orthopedic · 28d
Cleared Jan 18, 2024
Medline UNITE Ancillary Foot Recon Plating System
K234031 · HRS
Medline Industires, LP
Orthopedic · 29d
Cleared Jan 18, 2024
AMF TT Cones
K234011 · JWH
Lima Corporate S.P.A.
Orthopedic · 30d
Cleared Jan 18, 2024
Curiteva Porous PEEK Lumbar Interbody Fusion System
K233744 · MAX
Curiteva, Inc.
Orthopedic · 57d
Cleared Jan 18, 2024
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach...
K233680 · DTK
William Cook Europe Aps
Cardiovascular · 63d
Cleared Jan 18, 2024
EVOLUTION® Tibial Cones
K233507 · MBH
Microport Orthopedics, Inc.
Orthopedic · 79d
Cleared Jan 18, 2024
Arthrex Synergy Vision Endoscopic Imaging System
K233451 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 90d
Cleared Jan 18, 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · OPP
Cequr SA
Chemistry · 91d
Cleared Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 112d
Cleared Jan 18, 2024
NxStage PureFlow Solution
K233213 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 18, 2024
ENFit Adaptor
K233190 · PIO
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 112d
Cleared Jan 18, 2024
FlashHeal 2 (FlashHeal 2.0)
K233077 · GEX
Inwound Aps
General & Plastic Surgery · 114d
Cleared Jan 18, 2024
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope...
K232860 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 18, 2024
NemoScan
K232698 · QIH
Software Nemotec S.L.
Radiology · 135d
Cleared Jan 18, 2024
Radial Compression Device
K232577 · DXC
Ningbo Dizegens Medical Science Co.,Ltd
Cardiovascular · 146d
Cleared Jan 18, 2024
Progrip™ Self-Gripping Polypropylene Mesh
K232373 · FTL
Sofradim Production
General & Plastic Surgery · 163d
Cleared Jan 18, 2024
TDM Screw System
K231860 · HWC
Tdm Co., Ltd.
Orthopedic · 209d
Cleared Jan 18, 2024
uEXPLORER
K231762 · KPS
Shanghai United Imaging Healthcare...
Radiology · 216d
Cleared Jan 18, 2024
ThinkQA (Edition 2)
K231573 · IYE
Dosisoft SA
Radiology · 232d
Cleared Jan 18, 2024
Air Next (NVD-02)
K231416 · BZG
Nuvoair AB
Anesthesiology · 247d
Cleared Jan 18, 2024
Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile...
K231405 · GEI
Jiangsu Rong FU Kang Medical...
General & Plastic Surgery · 248d
Cleared Jan 18, 2024
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor...
K231166 · KPI
Zmi Electronics , Ltd.
Gastroenterology & Urology · 268d
Cleared Jan 18, 2024
LuxCreo Dental Night Guard Resin
K230592 · MQC
LuxCreo, Inc.
Dental · 321d