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
28465–28488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 27, 2017
Fully Automatic Blood Pressure Monitor
K171282 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jul 27, 2017
Nasal Alar SpO2 Sensor
K171423 · DQA
Xhale, Inc.
Anesthesiology · 73d
Cleared Jul 27, 2017
VISCO 360 Viscosurgical System
K171905 · MRH
Sight Sciences, Inc.
Ophthalmic · 31d
Cleared Jul 27, 2017
truFreeze System
K172041 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 2017
MagDen Dental Implant System
K162867 · DZE
Shinhung Mst Co., Ltd.
Dental · 286d
Cleared Jul 26, 2017
Orbit Inserter
K163400 · KZH
Ypsomed AG
General Hospital · 233d
Cleared Jul 26, 2017
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System
K163536 · PEX
Bruker Daltonik GmbH
Microbiology · 222d
Cleared Jul 26, 2017
wireless thermometer
K170769 · FLL
Ech (Changzhou) Medical Instrument...
General Hospital · 134d
Cleared Jul 26, 2017
HygePLUS Alginate Impression Material
K170812 · ELW
Hygedent, Inc.
Dental · 131d
Cleared Jul 26, 2017
BiopSee, Mobile US
K170841 · LLZ
Medcom GmbH
Radiology · 127d
Cleared Jul 26, 2017
NHAC 16
K171515 · MOS
Lmt Medical Systems GmbH
Radiology · 63d
Cleared Jul 26, 2017
Hydrocleanse Antimicrobial Skin and Wound Care Solution
K171727 · FRO
Sonoma Pharmaceuticals
General & Plastic Surgery · 44d
Cleared Jul 25, 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · LZA
Shen Wei (Usa), Inc.
General Hospital · 341d
Cleared Jul 25, 2017
PHMB Antimicrobial Foam Wound Dressing
K163062 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 265d
Cleared Jul 25, 2017
Easyret
K170067 · HQF
Quantel Medical
Ophthalmic · 197d
Cleared Jul 25, 2017
LightMed Dental Laser System
K170073 · GEX
Lightmed Dentaltechnology Corp.
General & Plastic Surgery · 197d
Cleared Jul 25, 2017
Spinal Manometer NRFit
K170305 · FMJ
PAJUNK GmbH Medizintechnologie
General Hospital · 175d
Cleared Jul 25, 2017
ANCHORMAN Tibial Ligament Fixation Device
K170388 · MBI
Summit Medical , Ltd.
Orthopedic · 167d
Cleared Jul 25, 2017
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · DQK
Biosense Webster, Inc.
Cardiovascular · 146d
Cleared Jul 25, 2017
CT Midline
K170770 · PND
Medical Components, Inc. (dba MedComp)
General Hospital · 133d
Cleared Jul 25, 2017
FTRD System Set
K170867 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 124d
Cleared Jul 25, 2017
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
K170997 · DYB
Biosense Webster, Inc.
Cardiovascular · 113d
Cleared Jul 25, 2017
Monteris Medical NeuroBlate System
K171255 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 88d
Cleared Jul 25, 2017
LumFuse-TP
K171630 · MAX
Precifit Medical, Ltd.
Orthopedic · 53d