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
The Evolve System with the Transform Applicator
InMode , Ltd.
BRAXX Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
Braxx Biotech Co., Ltd.
Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A)
Sanhe Laserconn Tech Co., Ltd.
IPL Hair Removal Device (BE965A, BE965B, BE965C)
Shenzhen Yang WO Electronic Co., Ltd.
Sterile syringes for single use with/without needle
Wepon Medical Technology Co., Ltd.
2.4mm Distal Radius System
Auxein Medical Private Limited
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs)
Taishan Weibang Medical Equipment Co., Ltd.
WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
Boston Scientific
AccuCheck
Manteia Technologies Co., Ltd.
Video Ureteroscope System
Hunan Vathin Medical Instrument Co., Ltd.
SKR 3000
Konica Minolta, Inc.
Small Bone Nailing System
Skeletal Dynamics, Inc.
Ulthera® System
Ulthera, Inc.
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
Omnispec ED1000
Medispec, Ltd.
VALO X, VALO X Accessory Lenses
Ultradent Products, Inc.
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
Boston Scientific Neuromodulation
Distal Elbow Plating System
Skeletal Dynamics, Inc.
VINT
Mediimg Corporation
Posterior Cervical Spine System
Double Medical Technology, Inc.
MagnetOs granules
Kuros Biosciences B.V
BEE HA
NGMedical GmbH
Saige-Dx (3.1.0)
DeepHealth, Inc.
INSULCLOCK® v2.0 PRO
Insulcloud S.L.
Quantra Hemostasis Analyzer
Hemosonics, LLC
LiquID .051 LP Guide Catheter Extension
Seigla Medical, Inc.
SCIg60 Infusion System
Emed Technologies Corporation
IPS e.max Zirconia
Ivoclar Vivadent, Inc.
Klox Biophotonic LumiHeal System
Klox Technlogies, Inc.
New Wave System
Zeto, Inc.
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