Search FDA 510(k) Database

7,042 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19537–19560 of 174,061
Cleared Dec 13, 2019
MyShoulder Placement Guides
K190738 · PHX
Medacta International S.A.
Orthopedic · 266d
Cleared Dec 13, 2019
EPIFLO-28
K190742 · KPJ
Neogenix, LLC Dba Ogenix
General & Plastic Surgery · 266d
Cleared Dec 13, 2019
Satisfaite
K190752 · NUC
Femmepharma Consumer Healthcare, LLC
Obstetrics & Gynecology · 263d
Cleared Dec 13, 2019
C50 and C80 Multi-parameter Patient Monitor
K191106 · MHX
Shenzhen Comen Medical Instruments...
Cardiovascular · 232d
Cleared Dec 13, 2019
Avanti Distal Radius and Forearm System
K191118 · HRS
Avanti Orthopaedics, Inc.
Orthopedic · 231d
Cleared Dec 13, 2019
Neo Cage System
K191796 · MAX
Neo Medical SA
Orthopedic · 163d
Cleared Dec 13, 2019
Icobrain
K192130 · LLZ
Icometrix NV
Radiology · 128d
Cleared Dec 13, 2019
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ...
K192152 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 126d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · NBW
I-Sens, Inc.
Chemistry · 120d
Cleared Dec 13, 2019
Aero Blue Performance Surgical Gowns
K192362 · FYA
O&M Halyard, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K192370 · DXT
Bayer Medical Care, Inc.
General Hospital · 105d
Cleared Dec 13, 2019
QyScore Software
K192531 · LLZ
Qynapse
Radiology · 88d
Cleared Dec 13, 2019
decimal3D
K192554 · MUJ
.Decimal, LLC
Radiology · 87d
Cleared Dec 13, 2019
Diode Laser Therapy System
K192569 · GEX
San HE Lefis Electronics Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 13, 2019
Laser Hair Growth Cap
K192627 · OAP
Shang FA Biotechnology Co.
General & Plastic Surgery · 81d
Cleared Dec 13, 2019
neria guard Infusion Set
K192647 · FPA
Unomedical A/S
General Hospital · 80d
Cleared Dec 13, 2019
Demetra BDEM-01 Dermatoscope
K192829 · PSN
Barco N.V.
General & Plastic Surgery · 72d
Cleared Dec 13, 2019
VaPro Plus Pocket, VaPro Plus
K193148 · GBM
Hollister Incorporated
Gastroenterology & Urology · 30d
Cleared Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared Dec 13, 2019
Deep Learning Image Reconstruction
K193170 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Dec 13, 2019
CareView 1800Le
K193173 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 25d
Cleared Dec 13, 2019
CrossTorq 14 Guidewire
K193194 · DQX
Scientia Cardio Access, LLC
Cardiovascular · 24d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Dec 13, 2019
CoreLite X-Ray Specimen Cabinet
K193317 · MWP
Cirdan Imaging Limited
Radiology · 14d