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
28969–28992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2017
Lympha Press Optimal Plus
K170658 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 89d
Cleared May 31, 2017
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
K170670 · JWY
bioMerieux, Inc.
Microbiology · 86d
Cleared May 31, 2017
ALLY(TM) Bone Screws
K170698 · HWC
Providence Medical Technology, Inc.
Orthopedic · 85d
Cleared May 31, 2017
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
K171268 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Cardiovascular · 30d
Cleared May 31, 2017
B R A H M S PCT sensitive KRYPTOR
K171338 · PRI
Brahms GmbH
Microbiology · 23d
Cleared May 31, 2017
EMS100 Tri-Wave Combination Stimulator
K171387 · IPF
Elite Medical Supply of New York, LLC
Physical Medicine · 20d
Cleared May 31, 2017
EndoWrist Stapler 45 System and Stapler 45 Reloads
K171388 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 20d
Cleared May 30, 2017
AmCAD-US
K162574 · LLZ
Amcad Biomed Corporation
Radiology · 257d
Cleared May 30, 2017
Pulse* Spray Infusion System, Uni*Fuse Infusion System
K163356 · QEY
AngioDynamics, Inc.
Cardiovascular · 181d
Cleared May 30, 2017
ARIETTA PRECISION
K163505 · IYN
Hitachi , Ltd.
Radiology · 167d
Cleared May 30, 2017
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
K163702 · IYN
Toshibamedical Systems Corporation
Radiology · 152d
Cleared May 30, 2017
TRINITY/3D PROSTATE SUITE
K170521 · IYN
Koelis
Radiology · 97d
Cleared May 30, 2017
FilmArray Respiratory Panel 2 (RP2)
K170604 · OCC
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared May 30, 2017
VenaCure EVLT NeverTouch Direct Introducer Sheath
K170695 · DYB
AngioDynamics, Inc.
Cardiovascular · 84d
Cleared May 30, 2017
27HJ713S
K170899 · GCJ
Lg Electronics
General & Plastic Surgery · 64d
Cleared May 30, 2017
Portable ECG Monitor
K170954 · DPS
Contec Medical Systems Co.,Ltd
Cardiovascular · 60d
Cleared May 30, 2017
gammaCore-S
K171306 · PKR
Electrocore, LLC
Neurology · 27d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Philips Health Care
Radiology · 26d
Cleared May 26, 2017
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing...
K162448 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared May 26, 2017
Creatine Kinase-MB
K162526 · JHW
Roche Diagnostics
Chemistry · 259d
Cleared May 26, 2017
Masimo O3 Regional Oximeter System
K162603 · MUD
Masimo Corporation
Cardiovascular · 249d
Cleared May 26, 2017
T3 Software
K163065 · MWI
Etiometry, Inc.
Cardiovascular · 205d
Cleared May 26, 2017
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
K163140 · OWB
Gemss Medical Systems Co., Ltd.
Radiology · 198d
Cleared May 26, 2017
MIS V3 Conical Connection Dental Implant System­
K163349 · DZE
Mis Implants Technologies , Ltd.
Dental · 178d