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
AXS Vecta 46 Intermediate Catheter
Stryker Neurovascular
Blood pressure monitor
Guangdong Transtek Medical Electronics Co., Ltd.
Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
Shanghai Waylong Intelligent Technology Co.,Ltd
LiveOne
Livemetric (Medical) S.A.
Elecsys Anti-Tg
Roche Diagnostics
Koala Intrauterine Pressure Catheter (IPC-5000E)
Clinical Innovations, LLC
Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co., Ltd.
Senhance Surgical System
Asensus Surgical, Inc.
PMMA Blocks for Dental Use
Aidite (Qinhuangdao) Technology Co., Ltd.
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Guangzhou Wondfo Biotech Co., Ltd.
Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
Merit Medical Systems, Inc.
Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
Avation Medical, Inc.
Medical Disposable Face Masks
Anqing Mayfield Medical Limited
RESPONDER® Polysaccharide Hemostat
Starch Medical, Inc.
BB 8 Sinus Dilation Kit
Excelent, Inc.
VFSS Pro Mobile Digital Imaging System
Imagexray, LLC
ZircaGlow & ZircaGlow HT Zirconia
United Zirconia
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
Nakanishi, Inc.
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
Innovative Health Technologies (Nz), Ltd.
EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Abla
ABBOTT MEDICAL
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
VATECH Co., Ltd.
Invisalign System
Align Technology, Inc.
KIDS Arterial Filters
Sorin Group Italia S.R.L.
Hybrid Viewer (00859873006189)
Hermes Medical Solutions AB
INNO SLA Mini Plus® Implant System
Cowellmedi Co., Ltd.
GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
Vascular Solutions, LLC
Tornier Pyrocarbon Humeral Head
Tornier S.A.S.
ORIO-3D Cage System
SpineCraft
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
VPIX Medical, Inc.
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