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
27817–27840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2017
DX-D Imaging Package
K172784 · MQB
Agfa Healthcare N.V.
Radiology · 28d
Cleared Oct 12, 2017
SONON Ultrasound Imaging System, Model: 300L
K170085 · IYN
Healcerion Co., Ltd.
Radiology · 275d
Cleared Oct 12, 2017
Galaxy UNYCO System
K170146 · KTT
Orthofix Srl
Orthopedic · 268d
Cleared CT Oct 12, 2017
Lucica Glycated Albumin-L
K170147 · LCP
Asahi Kasei Pharma Corporation
Chemistry · 268d
Cleared Oct 12, 2017
Creavo Vitalscan Magnetocardiograph
K170154 · DPS
Creavo Medical Technologies, Ltd.
Cardiovascular · 267d
Cleared Oct 12, 2017
MAGNETOM Terra
K170840 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 205d
Cleared Oct 12, 2017
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K171169 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 174d
Cleared Oct 12, 2017
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy...
K171279 · KGO
Top Glove Sdn. Bhd.
General Hospital · 164d
Cleared Oct 12, 2017
Mikron Spinal Fixation System
K171497 · MNI
Mikron Makina Sanayi Ticaret Co. , Ltd.
Orthopedic · 143d
Cleared Oct 12, 2017
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with...
K171782 · LZA
Blue Sail Medical Co.,Ltd
General Hospital · 119d
Cleared Oct 12, 2017
Vial Adapter 15mm
K171796 · LHI
Medimop Medical Project , Ltd.
General Hospital · 118d
Cleared Oct 12, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin...
K171874 · LZA
Hartalega Sdn Bhd
General Hospital · 111d
Cleared Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
K172305 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Oct 12, 2017
JUD custom fit condom
K172414 · HIS
Global Mailer Partners, LLC
Obstetrics & Gynecology · 63d
Cleared Oct 12, 2017
SKR 3000
K172793 · MQB
Konica Minolta, Inc.
Radiology · 27d
Cleared Oct 11, 2017
Stomach Tube
K162340 · KNT
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 415d
Cleared Oct 11, 2017
Nihon Kohden CO2 Monitor
K171765 · CCK
Nihon Kohden Corporation
Anesthesiology · 119d
Cleared Oct 11, 2017
Clickfine Pen Needle, Penfine Classic Pen Needle
K171984 · FMI
Ypsomed AG
General Hospital · 103d
Cleared Oct 11, 2017
U by Kotex Click Unscented Menstrual Tampons
K172118 · HEB
Kimberly Clark Corporation
Obstetrics & Gynecology · 90d
Cleared Oct 11, 2017
NuVasive® Modulus XLIF Interbody System
K172123 · MAX
Nu Vasive, Incorporated
Orthopedic · 89d
Cleared Oct 11, 2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
K172742 · FZP
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Oct 10, 2017
3M Bair Hugger Model 675 Total Temperature Management System
K171373 · DWJ
3M Company
Cardiovascular · 153d
Cleared Oct 10, 2017
InMode RF System
K171593 · GEI
Inmode MD , Ltd.
General & Plastic Surgery · 132d
Cleared Oct 10, 2017
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
K172724 · NKB
Stryker Corporation
Orthopedic · 29d