510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
Electric Scooter (FNS01,FNS03)
Anhui Jbh Medical Apparatus Co., Ltd.
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
Thompson Surgical Instruments, Inc.
Ivotion Base Print
Ivoclar Vivadent, Inc.
Dragonfly OpStar Imaging Catheter
ABBOTT MEDICAL
Diode Laser Therapy Device (DF-DIODE LASER-S1)
Weifang Dragonfly Electronics Technology Co., Ltd.
DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics, Inc.
BD Phoenix Automated Microbiology System
Becton, Dickinson and Company
ZENEX Implant System_Narrow
Izenimplant Co., Ltd.
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
Shenzhen Eyco Technology Co., Ltd.
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
MacroLux Medical Technology Co., Ltd.
NeuroMatch
LVIS Corporation
ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
Origyn Medical Technology (Hangzhou) Co., Ltd.
Stem Extension Line (U2 Total Knee SystemPSA Type)
United Orthopedic Corporation
Aperio GT 450 DX; Aperio GT 180 DX
Leica Biosystems Imaging, Inc.
ONE TRAY® Sealed Sterilization Container System
Innovative Sterilization Technologies
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 E
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Ticare Dental Implant Systems
Mozograu S.A.
Vitalograph Model 6000 Alpha
Vitalograph Ireland, Ltd.
Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
Tuttnauer , Ltd.
DiversiVy Facet Screw System
Vy Spine, LLC
Aptima® Chlamydia trachomatis Assay
Hologic, Inc.
Aesculap Aicon® Series Container System
Aesculap, Inc.
Wrist Type Blood Pressure Monitor
Shenzhen Jamr Medical Technology Co., Ltd.
Baby Gorilla®/Gorilla® Plating System
Paragon 28, Inc.
ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
Magnifico Open (100009900); Magnifico MSK ( 100009910)
Esaote, S.p.A.
V-Laser
Wontech Co., Ltd.
Arthrex Nano FiberTak Suture Anchor
Arthrex, Inc.
MyndMove 2.0
Myndtec, Inc.
Azurion R3.1
Philips Medical Systems B.V.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert