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
29905–29928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2016
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal,...
K161391 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 195d
Cleared Nov 30, 2016
SimplECG
K161431 · DXH
Nanowear, Inc.
Cardiovascular · 190d
Cleared Nov 30, 2016
One Drop Blood Glucose Monitoring System
K161834 · NBW
Agamatrix, Inc.
Chemistry · 148d
Cleared Nov 30, 2016
Protek Solo 24 Fr Venous Cannula Set
K162214 · DWF
Cardiacassist, Inc.
Cardiovascular · 114d
Cleared Nov 30, 2016
ESPADA Acne-Clearing Blue Light Pen
K162450 · OLP
Foreo, Inc.
General & Plastic Surgery · 90d
Cleared Nov 30, 2016
TxRx Knee 15 Flare MR Coil 1.5T
K162966 · MOS
Quality Electrodynamics, LLC
Radiology · 37d
Cleared Nov 30, 2016
Zeramex P6 Dental Implant System
K163043 · DZE
Dentalpoint AG
Dental · 30d
Cleared Nov 30, 2016
TubeClear Control Box and Clearing Stem
K163092 · KNT
Actuated Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 30, 2016
ReliaCatch Specimen Retrieval Bag 10mm
K163102 · GCJ
Covidien
General & Plastic Surgery · 23d
Cleared Nov 30, 2016
Clarius Ultrasound System
K163138 · IYN
Clarius Mobile Health Corp.
Radiology · 21d
Cleared Nov 30, 2016
PleuraFlow System with FlowGlide
K163139 · OTK
Clearflow, Inc.
General & Plastic Surgery · 21d
Cleared Nov 29, 2016
Medline ENFit Syringe
K160642 · PIF
Medline Industries, Inc.
Gastroenterology & Urology · 267d
Cleared Nov 29, 2016
Well Lead Extraction Bag
K160801 · GCJ
Well Lead Medical Co., Ltd.
General & Plastic Surgery · 251d
Cleared Nov 29, 2016
InnoSEAL Hemostatic Pad
K161013 · QSY
Innotherapy, Inc.
General & Plastic Surgery · 232d
Cleared Nov 29, 2016
Lenstec LC Injection system
K161776 · MSS
Lenstec, Inc.
Ophthalmic · 153d
Cleared Nov 29, 2016
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
K162414 · GKZ
Beckman Coulter, Inc.
Hematology · 92d
Cleared Nov 29, 2016
LuminScan (TM) Imaging System
K162466 · NQQ
Micro-Tech (Nanjing) Co., Ltd.
General & Plastic Surgery · 88d
Cleared Nov 29, 2016
TxRx Knee 15 Flare MR Coil 3.0T
K163066 · MOS
Quality Electrodynamics, LLC
Radiology · 27d
Cleared Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 277d
Cleared Nov 28, 2016
Carriere Motion Clear Class II
K160720 · DYW
Ortho Organizers, Inc.
Dental · 257d
Cleared Nov 28, 2016
Powder Free Polychloroprene Examination Glove Blue, Powder Free...
K161932 · LZA
Terang Nusa Sdn Bhd
General Hospital · 137d
Cleared Nov 28, 2016
VAMP Venous/Arterial Blood Management Protection System
K161962 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 133d
Cleared Nov 28, 2016
AccuFit Lateral Plate System
K162211 · KWQ
Precision Spine, Inc.
Orthopedic · 112d
Cleared Nov 28, 2016
Solana HSV 1+2/VZV Assay
K162451 · PGI
Quidel Corporation
Microbiology · 88d