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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

Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)

Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd.

uMR Jupiter

Shanghai United Imaging Healthcare Co., Ltd.

LiquiBand XL

Advanced Medical Solutions Limited

Disposable Medical Safety Hypodermic Needle

Hantech Medical Device Co., Ltd.

ZeTTA PACS

Tae Young Soft Co., Ltd.

Retraxil

Kulzer, LLC

Remunity System

Deka Research and Development

Genius AI Detection 2.0

Hologic, Inc.

ClearPoint Array System (Version 1.2)

ClearPoint Neuro, Inc.

PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops

Padm Medical, Inc.

Progressive Orthodontics App

Progressive Aligners, Inc.

Clover Glove

Clover Glove Company Limited

Innomed NPWT Silicone Foam Dressing

Zhejiang Longterm Medical Technology Co., Ltd.

SonoAir Series Digital Color Doppler Ultrasound System

CHISON Medical Technologies Co., Ltd.

Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mo

Olympus Medical Systems Corporation

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use

Jiangsu Zhiyu Medical Instrument Co, Ltd.

Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)

Sichuan Qianli-Beoka Medical Technology, Inc.

Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue;

Sri Trang Gloves Thailand (Public Company Limited)

3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix

Deltamed GmbH

TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

TriMed, Inc.

AVIEW Lung Nodule CAD

Coreline Soft Co., Ltd.

Collagen Wound Dressing

Winner Medical Co., Ltd.

ARTSMedia Semen Wash Medium

Artsmedia Denmark Aps

Glovmaster Nitrile Examination Glove Powder Free

Glovmaster Sdn. Bhd.

GlucoSure ADVANCE Link Blood Glucose Monitoring System

Apex BioTechnology Corp.

BriefCase

Aidoc Medical , Ltd.

Sonio Detect

Sonio

VELYS™ Hip Navigation

Depuy Ireland UC

Palmtop Ultrasound Diagnostic System (MT10P/MT10)

Mytech Intelligence (Shenzhen) Co., Ltd.

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); P

Nanjing Yinuoji Medical Technology Co., Ltd.

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