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
9457–9480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2023
Enamel Coating Resin
K230455 · EBC
Rizhao Huge Biomaterials Company, Ltd.
Dental · 154d
Cleared Jul 25, 2023
Sonio Detect
K230365 · IYN
Sonio
Radiology · 165d
Cleared Jul 25, 2023
ME-APDS™
K223473 · QNP
Magentiq Eye, Ltd.
Gastroenterology & Urology · 250d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 347d
Cleared Jul 25, 2023
Emit® II Plus Buprenorphine Assay
K221605 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 418d
Cleared Jul 25, 2023
DEKA ACE Pump System
K213536 · QFG
Deka Research and Development
Chemistry · 627d
Cleared Jul 24, 2023
EsCom250
K231523 · EBF
Spident Co., Ltd.
Dental · 59d
Cleared Jul 24, 2023
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish...
K230333 · LBH
Kettenbach GmbH & Co. KG
Dental · 167d
Cleared Jul 24, 2023
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with...
K223752 · LZA
Central Medicare Sdn Bhd
General Hospital · 221d
Cleared Jul 24, 2023
UltraSight AI Guidance
K223347 · QJU
Ultrasight, Inc.
Radiology · 265d
Cleared Jul 24, 2023
Argus Cognitive ReVISION Software
K223322 · LLZ
Argus Cognitive, Inc.
Radiology · 266d
Cleared Jul 23, 2023
Atlan
K230931 · BSZ
Dr?gerwerk AG & Co KGaA
Anesthesiology · 111d
Cleared Jul 21, 2023
TruDi® Navigation System V3 (FG-2000-00)
K231862 · PGW
Acclarent, Inc.
Ear, Nose, Throat · 28d
Cleared Jul 21, 2023
EndoflipTM 300 System
K231861 · FFX
Covidien, LLC
Gastroenterology & Urology · 28d
Cleared Jul 21, 2023
Triever20 Curve (21-201)
K231848 · QEW
Inari Medical, Inc.
Cardiovascular · 28d
Cleared Jul 21, 2023
INHANCE™ Shoulder System, Sterile Single Use Instrumentation
K231516 · MBF
Depuy Ireland UC
Orthopedic · 57d
Cleared Jul 21, 2023
MySpine Unilateral Guides
K231483 · PQC
Medacta International S.A.
Orthopedic · 59d
Cleared Jul 21, 2023
Erchonia Violet ZERONA® Z6 OTC
K231474 · OLI
Erchonia Corporation
General & Plastic Surgery · 60d
Cleared Jul 21, 2023
Irregular Rhythm Notification Feature (IRNF)
K231173 · QDB
Apple, Inc.
Cardiovascular · 87d
Cleared Jul 21, 2023
0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
K231161 · NGT
Becton, Dickinson and Company
General Hospital · 88d
Cleared Jul 21, 2023
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with...
K231021 · LZA
Kimberly Clark Corporation
General Hospital · 102d
Cleared Jul 21, 2023
enspire 300 Series Automated Endoscope Reprocessor System
K230560 · NZA
STERIS Corporation
General Hospital · 143d
Cleared Jul 21, 2023
OptimMRI
K230150 · QIH
Rebrain, Sas
Radiology · 183d
Cleared Jul 21, 2023
NextAR™ Spine Platform
K223769 · SBF
Medacta International S.A.
Orthopedic · 218d