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
14977–15000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2022
DeGen Navigated Instrumentation
K213918 · OLO
Degen Medical
Orthopedic · 56d
Cleared Feb 09, 2022
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™...
K214011 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Feb 09, 2022
SDC4K Information Management System with Device and Voice Control Package
K220108 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 27d
Cleared Feb 08, 2022
PathBuilder Steerable Introducer
K211530 · DYB
Shanghai Microport EP Medtech Co., Ltd.
Cardiovascular · 267d
Cleared Feb 08, 2022
O'Star Nitrile Examination Gloves Powder Free
K213058 · LZA
Star Investment and Trade Joint Stock...
General Hospital · 139d
Cleared Feb 08, 2022
Rapid
K213165 · LLZ
Ischemaview, Inc.
Radiology · 133d
Cleared Feb 08, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · DYB
Acutus Medical, Inc.
Cardiovascular · 34d
Cleared Feb 07, 2022
ELEC-LED
K201191 · EBW
Micro-Nx Co., Ltd.
Dental · 644d
Cleared Feb 07, 2022
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
K212431 · JDG
Biomet, Inc.
Orthopedic · 187d
Cleared Feb 04, 2022
Noris Medical Dental Implants System
K210356 · NHA
Noris Medical , Ltd.
Dental · 361d
Cleared Feb 04, 2022
F3D-C2 Cervical Stand-Alone System
K211417 · OVE
Corelink, LLC
Orthopedic · 273d
Cleared Feb 04, 2022
smart-sync
K212271 · LNH
Northh Medical GmbH
Radiology · 199d
Cleared Feb 04, 2022
Magnifico Open, Magnifico MSK
K212419 · LNH
Esaote, S.P.A.
Radiology · 184d
Cleared Feb 04, 2022
Micro C Medical Imaging System, M01
K212654 · IZL
Oxos Medical, Inc.
Radiology · 165d
Cleared Feb 04, 2022
Genex Bone Graft Substitute
K212721 · MQV
Biocomposites, Ltd.
Orthopedic · 161d
Cleared Feb 04, 2022
BD Vacutainer UltraTouch Push Button Blood Collection Set
K212724 · JKA
Becton, Dickinson and Company
General Hospital · 161d
Cleared Feb 04, 2022
VenSure LightGuide
K212774 · LRC
Intersect Ent.
Ear, Nose, Throat · 156d
Cleared Feb 04, 2022
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · LON
Biom?rieux, Inc.
Microbiology · 150d
Cleared Feb 04, 2022
HOLLYWOOD SPECTRA Laser System
K213569 · GEX
Lutronic Corporation
General & Plastic Surgery · 87d
Cleared Feb 04, 2022
Stryker Resorbable Fixation System
K213777 · JEY
Stryker Leibinger Micro Implants
Dental · 63d
Cleared Feb 04, 2022
Veuron-Brain-pAb2
K213801 · LLZ
Heuron Co., Ltd.
Radiology · 60d
Cleared Feb 04, 2022
Revolution Ascend
K213938 · JAK
Ge Healthcare Japan Corporation
Radiology · 50d
Cleared Feb 04, 2022
Radialis PET Camera
K214062 · KPS
Radialis, Inc.
Radiology · 39d
Cleared Feb 04, 2022
Cryo 7
K220020 · GEX
Zimmer Medizinsysteme GmbH
General & Plastic Surgery · 30d