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
Dental Electric Motor
Foshan Cicada Dental Instrument Co, Ltd.
Strut Suture; No-Tie Button
Riverpoint Medical, LLC
VitalSigns 1-Lead Holter (VSH101)
VitalSigns Technology Co., Ltd.
Disposable Nitrile Gloves
Jiangsu Shenglijie Safety Products Co., Ltd.
FORUM
Carl Zeiss Meditec, AG
Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Cat
Vein 360, LLC
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coil
Invivo Corporation
Myocene
Myocene
Navigo Workstation 2.3 (FPRMC00039)
UC-CARE , Ltd.
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Sanhe Laserconn Tech Co., Ltd.
MRIdian Linac System
Viewray, Incorporated
GEM Premier 5000
Instrumentation Laboratory CO
VIDAS NEPHROCHECK
Biomérieux SA
Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC
XNY Disposable Gastric Calibration Tube
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Coltolux Comfort LED Curing Light
Dent4you AG
Power Wheelchair (N5515A, N5516, N5517A, N5519)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Galileo Vertebral Body Replacement Device
Bright Spine
Disposable Medical Nitrile gloves
Guangdong Xingcan Brothers Medical Technology Co.,Ltd
TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.
BIS Advance Monitoring System
Covidien, LLC
Resonic Rapid Acoustic Pulse Device
Zeltiq Aesthetics, Inc.
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
Philips Ultrasound, LLC
Ochsner Connected Inhaler Sensor
Ochsner Clinic Foundation
Limbus Contour
Limbus Ai, Inc.
Tera Harz Clear
Graphy, Inc.
Access Myoglobin
Beckman Coulter, Inc.
IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
Medicrea International S.A.S. (Medtronic)
EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19)
Cook Ireland, Ltd.
Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i
Canon Medical Systems Corporation
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