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
7801–7824 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 16, 2024
Disposable safety lancet (Impress)
K233796 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 48d
Cleared Jan 16, 2024
Rapid (6.0)
K233512 · QIH
Ischemaview, Inc.
Radiology · 76d
Cleared Jan 16, 2024
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
K233293 · QGL
Neurosigma, Inc.
Neurology · 109d
Cleared Jan 16, 2024
Non absorbable Surgical Silk Suture
K232355 · GAP
Shandong Haidike Medical Product Co.,...
General & Plastic Surgery · 162d
Cleared Jan 16, 2024
Uni-port
K232062 · OTJ
Dalim Medical Corp.
General & Plastic Surgery · 189d
Cleared Jan 16, 2024
Washtrays
K231144 · KCT
Dentsply Sirona
General Hospital · 270d
Cleared Jan 16, 2024
Aniti-Snore Mouthguard+
K231138 · LRK
Oscimed SA
Dental · 270d
Cleared Jan 16, 2024
Hilzo Esophageal Stents
K223266 · ESW
Thoracent, Inc.
Gastroenterology & Urology · 449d
Cleared Jan 16, 2024
Delta4 Insight
K223234 · IYE
Scandidos AB
Radiology · 454d
Cleared Jan 13, 2024
CLEWICU System
K233216 · QNL
Clew Medical , Ltd.
Cardiovascular · 107d
Cleared Jan 13, 2024
Stryker Facial iD System
K232350 · JEY
Stryker Craniomaxillofacial
Dental · 159d