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
24001–24024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 2018
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
K182088 · GEX
Fotona D.O.O.
General & Plastic Surgery · 90d
Cleared Oct 31, 2018
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
K182588 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 41d
Cleared Oct 31, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
K182679 · IYN
Canon Medical Systems Corporation
Radiology · 35d
Cleared Oct 31, 2018
Halifax Imaging Kit
K182880 · KPR
Halifax Biomedical, Inc.
Radiology · 16d
Cleared Oct 30, 2018
UroGen Ureteral Catheter
K180354 · KOD
Urogen Pharma, Ltd.
Gastroenterology & Urology · 264d
Cleared Oct 30, 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · DYW
Tomy, Inc.
Dental · 225d
Cleared Oct 30, 2018
LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
K181488 · FZP
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 146d
Cleared Oct 30, 2018
Cios Spin
K181550 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 139d
Cleared Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · JOY
Sysmex America, Inc.
Hematology · 90d
Cleared Oct 30, 2018
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides,...
K182063 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 30, 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · KOB
Cook Incorporated
Gastroenterology & Urology · 90d
Cleared Oct 30, 2018
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides,...
K182072 · CGZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 30, 2018
Wilson-Cook Mini Basket
K182381 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 30, 2018
Frozen C
K182392 · GEH
B.M. Tech. Worldwide Co., Ltd.
General & Plastic Surgery · 56d
Cleared Oct 30, 2018
AOS Calcaneal Plating System
K182466 · HRS
Advanced Orthopaedic Solutions
Orthopedic · 50d
Cleared Oct 30, 2018
DiLumen Endolumenal Interventional Platform
K182540 · FDF
Lumendi, LLC
Gastroenterology & Urology · 46d
Cleared Oct 29, 2018
HemoScreen Hematology Analyzer
K180020 · GKZ
Pixcell Medical Technologies, Ltd.
Hematology · 300d
Cleared Oct 29, 2018
HSV 1 & 2 ELITe MGB Kit
K180559 · PGI
Elitechgroup
Microbiology · 242d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 29, 2018
ClearLink Controlled Phototherapy Equipment
K182215 · FTC
Daavlin Distributing Company
General & Plastic Surgery · 75d
Cleared Oct 29, 2018
MC3 Vascular Access Kit 21030
K182914 · DRE
Mc3 Incorporated
Cardiovascular · 11d
Cleared Oct 27, 2018
ORTHROS™ Posterior Stabilization System
K180980 · NKB
Camber Spine Technologies, LLC
Orthopedic · 197d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d
Cleared Oct 26, 2018
Biomate Dental Implant System
K170732 · DZE
Biomate Medical Devices Technology...
Dental · 595d