Search FDA 510(k) Database

6,683 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
11953–11976 of 174,061
Cleared Jul 01, 2022
Insulin Pen Needle
K221176 · FMI
Tianjin Huahong Technology Co., Ltd.
General Hospital · 67d
Cleared Jul 01, 2022
Footmotion Plating System
K221395 · HRS
Newclip Technics
Orthopedic · 49d
Cleared Jul 01, 2022
2-Way 100% Silicone ClearTract Catheter
K221625 · EZL
Silq Technologies Corporation
Gastroenterology & Urology · 25d
Cleared Jul 01, 2022
J-Temp
K221909 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jun 30, 2022
Cholesterol2
K203597 · CHH
Abbott Ireland Diagnostics Division
Chemistry · 568d
Cleared Jun 30, 2022
hCG One Step Pregnancy Test
K212418 · LCX
Healstone Biotech, Inc.
Chemistry · 331d
Cleared Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue...
K212785 · DZE
Blue Sky Bio, LLC
Dental · 302d
Cleared Jun 30, 2022
Epicardial Access System
K213582 · DYB
Baylis Medical Company, Inc.
Cardiovascular · 230d
Cleared Jun 30, 2022
leva Pelvic Health System
K213913 · HIR
Renovia, Inc.
Gastroenterology & Urology · 197d
Cleared Jun 30, 2022
VASSALLO GT 018 Floppy
K213949 · DQX
Filmecc Co., Ltd.
Cardiovascular · 195d
Cleared Jun 30, 2022
Sparta 3-Ply Surgical Disposable Face Mask
K220378 · FXX
Sparta East, LLC
General Hospital · 140d
Cleared Jun 30, 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · LOX
Abbott Vascular
Cardiovascular · 118d
Cleared Jun 30, 2022
Wrist Type Blood Pressure Monitor
K220651 · DXN
Shenzhen Jamr Medical Technology Co.,...
Cardiovascular · 115d
Cleared Jun 30, 2022
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System,...
K221050 · OUR
Aegis Spine, Inc.
Orthopedic · 80d
Cleared Jun 30, 2022
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
K221569 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 30d
Cleared Jun 30, 2022
InMode Multi-system
K221571 · GEX
Inmode , Ltd.
General & Plastic Surgery · 30d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750 · DQY
Abbott Medical
Cardiovascular · 14d
Cleared Jun 29, 2022
Powered Breast Pump (Models 7V and 7X)
K211016 · HGX
Haenim Co., Ltd.
Obstetrics & Gynecology · 450d
Cleared Jun 29, 2022
Kerecis Silicone
K213231 · KGN
Kerecis Limited
General & Plastic Surgery · 272d
Cleared Jun 29, 2022
Eko Murmur Analysis Software (EMAS)
K213794 · DQD
Eko Devices, Inc.
Cardiovascular · 205d
Cleared Jun 29, 2022
Coloring Liquid
K220017 · EIH
Dongguan Xiangtong Co., Ltd.
Dental · 175d
Cleared Jun 29, 2022
FridaMom Anti-Nausea Bands
K220289 · MVV
Fridababy, LLC
Neurology · 148d
Cleared Jun 29, 2022
ARTIS pheno (VE21) System
K220409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 135d
Cleared Jun 29, 2022
Ebony HP PTA OTW 0.035 Catheter
K220410 · LIT
Natec Medical , Ltd.
Cardiovascular · 135d