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
19585–19608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 17, 2020
myQA iON
K201798 · LHN
Iba Dosimetry GmbH
Radiology · 17d
Cleared Jul 16, 2020
ZCA All-Poly Acetabular Cups
K191449 · JDI
Zimmer, Inc.
Orthopedic · 412d
Cleared Jul 16, 2020
TiN Coated Humeral Head
K191698 · KWT
Fx Shoulder USA, Inc.
Orthopedic · 387d
Cleared Jul 16, 2020
KeraStat Cream
K192386 · KGN
Keranetics
General & Plastic Surgery · 317d
Cleared Jul 16, 2020
Arm Blood Pressure Monitor
K193456 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 216d
Cleared Jul 16, 2020
Vivid S60N, Vivid S70N
K200497 · IYN
GE Medical Systems Ultrasound and...
Radiology · 139d
Cleared Jul 16, 2020
Infrared Thermometer Model Number RN-50A,RN-50B
K200578 · FLL
Ningbo Ranor Medical Science &...
General Hospital · 133d
Cleared Jul 16, 2020
FibroScan® 630
K200655 · IYO
Echosens
Radiology · 126d
Cleared Jul 16, 2020
HealthMammo
K200905 · QFM
Zebra Medical Vision, Ltd.
Radiology · 101d
Cleared Jul 16, 2020
Geneva
K201272 · JAQ
Nucletron B.V.
Radiology · 65d