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
22393–22416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
K183088 · GGT
Axis-Shield Diagnostics Limited
Hematology · 269d
Cleared Aug 02, 2019
Elaris Pedicle Screw System
K183091 · NKB
Spinewelding AG
Orthopedic · 269d
Cleared Aug 02, 2019
DiLumen Endolumenal Interventional Knife (“DiLumen IK™”)
K183112 · GEI
Lumendi, LLC
Gastroenterology & Urology · 267d
Cleared Aug 02, 2019
DynoSense Vital Sign Measuring System
K190090 · MWI
Dynosense Corp.
Cardiovascular · 197d
Cleared Aug 02, 2019
Single Use Cytology Brush BC-205D
K190293 · BTG
Olympus Medical Systems Corp.
Anesthesiology · 172d
Cleared Aug 02, 2019
046 Zenith Flex
K190338 · NRY
Inneuroco, Inc.
Neurology · 169d
Cleared Aug 02, 2019
PowerFlow Implantable Apheresis IV Port
K191143 · PTD
C.R. Bard, Inc.
General Hospital · 94d
Cleared Aug 02, 2019
JAZZ PF
K191217 · OWI
Implanet, S.A.
Orthopedic · 88d
Cleared Aug 02, 2019
Primelase Excellence
K191321 · GEX
High Technology Products S.L.U
General & Plastic Surgery · 79d
Cleared Aug 02, 2019
Rezum System
K191505 · KNS
Nxthera (A Boston Scientific Company)
Gastroenterology & Urology · 57d
Cleared Aug 02, 2019
Epicardial Access System
K191546 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 51d
Cleared Aug 02, 2019
APA Oxy Blade
K191602 · CCW
Venner Medical (Singapore) Pte, Ltd.
Anesthesiology · 46d
Cleared Aug 02, 2019
Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization...
K191741 · JOJ
Intertape Polymer, Inc.
General Hospital · 32d
Cleared Aug 02, 2019
MobileDiagnost wDR 2.2
K191813 · IZL
Sedecal., Sa.
Radiology · 28d
Cleared Aug 01, 2019
LOQTEQ VA Calcaneus Plate 3.5
K182818 · HRS
Aap Implantate AG
Orthopedic · 302d
Cleared Aug 01, 2019
Mini TENS Therapy Device
K182871 · NUH
Shenzhen Jumper Medical Equipment...
Neurology · 293d
Cleared Aug 01, 2019
MREplus+ Software
K183193 · LLZ
Resoundant, Inc.
Radiology · 255d
Cleared Aug 01, 2019
Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super...
K183590 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 223d
Cleared Aug 01, 2019
MINAMO
K190176 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 181d
Cleared Aug 01, 2019
Leksell Vantage Stereotactic System
K190887 · HAW
Elekta Instrument AB
Neurology · 119d
Cleared Aug 01, 2019
Steerable Introducer
K191190 · DYB
Freudenberg Medical, LLC
Cardiovascular · 90d
Cleared Aug 01, 2019
SurgTech GENOLL Total Knee System
K191192 · JWH
Surgtech, Inc.
Orthopedic · 90d
Cleared Aug 01, 2019
JO Premium Jelly Original Personal Lubricant
K191214 · NUC
United Consortium
Obstetrics & Gynecology · 87d
Cleared Aug 01, 2019
ImagingRing System on Rails
K191267 · IYE
Medphoton GmbH
Radiology · 83d