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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