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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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