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
8065–8088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 18, 2024
S-Plant Dental Implant System
K221866 · DZE
Newton Implant Systems, Inc.
Dental · 570d
Cleared Jan 17, 2024
Clear Guide SCENERGY
K234030 · JAK
Clear Guide Medical
Radiology · 28d
Cleared Jan 17, 2024
Cerenovus Large Bore Catheter
K233988 · NRY
Cerenovus, Inc.
Neurology · 30d
Cleared Jan 17, 2024
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
K233783 · DSY
Peca Labs, Inc.
Cardiovascular · 51d
Cleared Jan 17, 2024
Footprint Mini PK, 3.5mm Suture Anchor
K233730 · MBI
Smith & Nephew
Orthopedic · 57d
Cleared Jan 17, 2024
Symphion Operative Hysteroscopy System
K233710 · PGT
Minerva Surgical, Inc.
Obstetrics & Gynecology · 58d
Cleared Jan 17, 2024
Bactiseal Catheters
K233445 · JXG
Integra Lifesciences Production...
Neurology · 90d
Cleared Jan 17, 2024
FlexView Diagnostic (v1.1.20)
K233226 · LLZ
Radical Imaging, LLC
Radiology · 111d
Cleared Jan 17, 2024
M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore...
K233031 · KNW
Canyon Medical, Inc.
General & Plastic Surgery · 114d
Cleared Jan 17, 2024
Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20,...
K232732 · LDJ
Co-Innovation Biotech Co., Ltd.
Toxicology · 132d
Cleared Jan 17, 2024
Radify Triage
K231871 · QFM
Envisionit Deepai, Ltd.
Radiology · 205d
Cleared Jan 17, 2024
Video Ureteroscope System
K231135 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 271d
Cleared Jan 16, 2024
Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use...
K233970 · LZA
Nephron Nitrile, LLC
General Hospital · 32d