FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
25441–25464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2018
SEKURE HbA1c Assay
K173206 · PDJ
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 283d
Cleared Jul 12, 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · NBW
Taidoc Technology Corporation
Chemistry · 241d
Cleared Jul 12, 2018
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
K173627 · NLQ
Surgical Instrument Service and...
General & Plastic Surgery · 230d
Cleared Jul 12, 2018
Modified Novy Cornual Cannulation Set
K180552 · MOV
Cook Incorporated
Obstetrics & Gynecology · 133d
Cleared Jul 12, 2018
THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm,...
K180575 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 129d
Cleared Jul 12, 2018
Estelite Universal Flow
K180613 · EBF
Tokuyama Dental Corporation
Dental · 126d
Cleared Jul 12, 2018
FBC 921 (ALIF)
K180695 · OVD
Fbc Device Aps
Orthopedic · 118d
Cleared Jul 12, 2018
AIM2
K181011 · ELW
GC America, Inc.
Dental · 86d
Cleared Jul 12, 2018
StatStrip Glucose Hospital Meter System
K181043 · PZI
Nova Biomedical Corporation
Chemistry · 84d
Cleared Jul 12, 2018
CONOD Enteral Feeding Sets
K181276 · PIF
Conod Medical Co., Limited
Gastroenterology & Urology · 59d
Cleared Jul 12, 2018
Catalyst CSR Shoulder System
K181287 · KWT
Catalyst Orthoscience, Inc.
Orthopedic · 57d
Cleared Jul 11, 2018
High-speed Turbine Handpieces for Single Use
K172543 · EFB
Beijing Dongbo Dental Handpiece Co.,...
Dental · 322d
Cleared Jul 11, 2018
NTU-USB Ultrasound USB Box
K173486 · IYN
National Taiwan University
Radiology · 240d
Cleared Jul 11, 2018
Intelli-C
K173631 · OWB
Nrt X-Ray A/S
Radiology · 229d
Cleared Jul 11, 2018
Transcranial Doppler Ultrasound System
K173801 · IYN
Shenzhen Delica Medical Equipment...
Radiology · 209d
Cleared Jul 11, 2018
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
K173881 · FMI
Owen Mumford, Ltd.
General Hospital · 202d
Cleared Jul 11, 2018
Medicalgorithmics Unified Cardiac Rehabilitation System
K173969 · DSI
Medicalgorithmics S.A.
Cardiovascular · 194d
Cleared Jul 11, 2018
SALVATION Midfoot Nail
K180024 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 189d
Cleared Jul 11, 2018
Infrared Thermometer
K180314 · FLL
Xuzhou Yongkang Electronic Science...
General Hospital · 156d
Cleared Jul 11, 2018
Aspire Introducer Needle
K180725 · KNT
Aspire Bariatrics, Inc.
Gastroenterology & Urology · 113d
Cleared Jul 11, 2018
INVISION Total Ankle Revision System
K180730 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 113d
Cleared Jul 11, 2018
Ziehm RFD 3D Tracker
K180816 · OLO
Medtronic Navigation
Orthopedic · 104d
Cleared Jul 11, 2018
ROCCIA ALIF, ROCCIA TLIF
K180963 · MAX
Silony Medical GmbH
Orthopedic · 90d
Cleared Jul 11, 2018
Dental Diode Laser System
K180967 · GEX
Lazon Medical Laser Co., Ltd.
General & Plastic Surgery · 89d