FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
18985–19008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2020
Owgels Oxygen Concentrator
K191875 · CAW
Guangzhou Life Light Electronic...
Anesthesiology · 374d
Cleared Jul 20, 2020
Intravascular Extension Sets and Accessories
K192366 · FPA
Baxter Healthcare Corporation
General Hospital · 325d
Cleared Jul 20, 2020
Retractable Safety Insulin Syringe
K193022 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 264d
Cleared Jul 20, 2020
CERENOVUS Large Bore Catheter
K193380 · NRY
Codman & Shurtleff, Inc.
Neurology · 228d
Cleared Jul 20, 2020
BioSiCar Silicone Implant
K193392 · MIB
Metalware Technology Corp.
General & Plastic Surgery · 227d
Cleared Jul 20, 2020
Benesta Medical Sterilization Tray
K193603 · KCT
Caldera Medical, Inc.
General Hospital · 210d
Cleared Jul 20, 2020
GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
K201179 · DQA
Covidien, LLC
Anesthesiology · 80d
Cleared Jul 20, 2020
Smith+Nephew Arthroscopes
K201349 · HRX
Smith & Nephew
Orthopedic · 60d
Cleared Jul 17, 2020
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III...
K192793 · FDF
Olympus Medical Systems Corp.
Gastroenterology & Urology · 291d
Cleared Jul 17, 2020
Cryocheck Chromogenic Factor VIII
K193204 · GGP
Precision Biologic
Hematology · 240d
Cleared Jul 17, 2020
Syringe with safety needle, Safety needle
K193526 · FMF
Jiangsu Caina Medical Co.,Ltd
General Hospital · 211d
Cleared Jul 17, 2020
AeroEclipse* ONE BAN
K200063 · CAF
Trudell Medical International
Anesthesiology · 186d
Cleared Jul 17, 2020
SCENARIA View
K200498 · JAK
Hitachi Healthcare Americas
Radiology · 140d
Cleared Jul 17, 2020
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera...
K200542 · OWN
Olympus Medical Systems Corp.
General & Plastic Surgery · 136d
Cleared Jul 17, 2020
Synvitro Hyadase
K200680 · MQL
Origio A/S, A Coopersurgical Company
Obstetrics & Gynecology · 123d
Cleared Jul 17, 2020
3DMax MID Anatomical Mesh
K200818 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 109d
Cleared Jul 17, 2020
Ambu Duodeno System
K201098 · FDT
Ambu Innovation GmbH
Gastroenterology & Urology · 84d
Cleared Jul 17, 2020
S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO,...
K201198 · GCJ
Smith & Nephew
General & Plastic Surgery · 74d
Cleared Jul 17, 2020
Phantom® Hindfoot TTC/TC Nail System
K201227 · HSB
Paragon 28, Inc.
Orthopedic · 72d
Cleared Jul 17, 2020
LINK TrabecuLink Femoral Cones
K201364 · MBH
Waldemar Link GmbH & Co. KG
Orthopedic · 56d
Cleared Jul 17, 2020
True 3D Viewer
K201365 · LLZ
Echopixel, Inc.
Radiology · 56d
Cleared Jul 17, 2020
SuRgical Planner (SRP) BrainStorm
K201465 · LLZ
Surgical Theater, Inc.
Radiology · 45d
Cleared Jul 17, 2020
Rover
K201488 · IZL
Micro-X , Ltd.
Radiology · 43d
Cleared Jul 17, 2020
Signia Stapler (with new software)
K201672 · GDW
Covidien
General & Plastic Surgery · 28d