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
22369–22392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2019
EmboCube Embolization Gelatin
K183120 · KRD
Biosphere Medical, S.A.
Cardiovascular · 270d
Cleared Aug 06, 2019
M3290B Patient Information Center iX
K183387 · MHX
Philips Medical Systems
Cardiovascular · 243d
Cleared Aug 06, 2019
exoplan 2.3
K183458 · LLZ
Exocad GmbH
Radiology · 236d
Cleared Aug 06, 2019
ENFit Oral / Enteral Syringe
K190502 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 158d
Cleared Aug 06, 2019
BiMobile Dual Mobility System - E-Dur Inserts
K190535 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 155d
Cleared Aug 06, 2019
OrthoPediatrics PediFoot Deformity Corrections System
K190992 · HRS
OrthoPediatrics Corp.
Orthopedic · 113d
Cleared Aug 06, 2019
The AIO Solution
K191158 · IYE
Orfit Industries NV
Radiology · 97d
Cleared Aug 06, 2019
Percutaneous Introducer Needle
K191295 · GCJ
Progressive Medical, Inc.
General & Plastic Surgery · 84d
Cleared Aug 06, 2019
Normandy VBR System
K191423 · PLR
Zavation Medical Products, LLC
Orthopedic · 69d
Cleared Aug 06, 2019
Endoskeleton TCS Interbody Fusion Device
K191565 · OVE
Titan Spine, Inc.
Orthopedic · 54d
Cleared Aug 06, 2019
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
K191781 · LZO
Zimmer GmbH
Orthopedic · 35d
Cleared Aug 06, 2019
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
K191835 · NKB
Globus Medical, Inc.
Orthopedic · 28d
Cleared Aug 05, 2019
Crossing Support Catheter
K183305 · DQY
Tractus Vascular, LLC
Cardiovascular · 250d
Cleared Aug 05, 2019
UPJ Occlusion Balloon Catheter
K183323 · EYB
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Aug 05, 2019
Beddr 200 System
K190399 · DQA
Hancock Medical, Inc.
Anesthesiology · 167d
Cleared Aug 05, 2019
LunaGuard Nighttime Dental Protector
K191033 · OBR
Mckeon Products
Dental · 109d
Cleared Aug 05, 2019
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech...
K191222 · NHA
Prismatik Dentalcraft, Inc.
Dental · 90d
Cleared Aug 05, 2019
EEG Electrode Template
K191225 · GXY
Rhythmlink International, LLC
Neurology · 90d
Cleared Aug 05, 2019
aBSI
K191262 · LLZ
Exini Diagnostics AB
Radiology · 87d
Cleared Aug 05, 2019
TDS Standard Solution
K191496 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 05, 2019
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
K191766 · LON
bioMerieux, Inc.
Microbiology · 35d
Cleared Aug 05, 2019
FLUOROspeed
K191877 · JAA
Shimadzu Corporation
Radiology · 21d
Cleared Aug 02, 2019
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital...
K181154 · DXN
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 458d
Cleared Aug 02, 2019
HAMILTON-T1, HAMILTON-C1
K181216 · CBK
Hamilton Medical AG
Anesthesiology · 452d