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
Filter and HME/Filter
Ningbo Huakun Medical Equipment Co., Ltd.
LM-9300 Plus Lithotripter
Lite-Med, Inc.
Revolution Ascend Sliding
Ge Hangwei Medical Systems Co., Ltd.
ZAFIRA®
New Stetic, SA
Electrically Powered Wheelchair -Model HP358E
Kunshan Hi-Fortune Health Products Co., Ltd.
Smooth Drive contra angle and straight handpieces
Lares Research
CORE1 Implant System
Cybermed, Inc.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
Hunan Haipuming Technology Co., Ltd.
Materialise TKA Guide System
Materialise NV
CalcShift Displacement Calcaneal Osteotomy System
Nextremity Solutions, Inc.
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
Acumed, LLC
Smartlux Mini
Medmix Co., Ltd.
SIGNA Artist Evo
Ge Healthcare (Tianjin) Company Limited
Electric breast pump
Dongguan Rongfeng Medical Co., Ltd.
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Qu
Hycor Biomedical
syngo Dynamics (Version VA40E)
Siemens Medical Solutions USA, Inc.
Terumo Advanced Perfusion System 1
Terumo Cardiovascular Systems Corporation
NeuroAlign software
Medivis, Inc.
BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Vivachek Biotech (Hangzhou) Co., Ltd.
CoLumbo
Smart Soft Healthcare AD
NSite Scoliosis Assessment App
Nsite, Inc.
Isolator Synergy EnCapture Ablation System (EMH)
AtriCure, Inc.
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model
STERIS Corporation
ImmersiveTouch
Immersivetouch, Inc.
2-Way 100% Silicone Cleartract Catheter
Silq Technologies Corporation
Astroglide Warming
Biofilm, Inc.
zLOCK Lumbar Facet Fixation System
Zygofix , Ltd.
uMR Omega
Shanghai United Imaging Healthcare Co., Ltd.
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacua
Modern Medical Equipment Manufacturing, Ltd.
Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance
Ambu A/S
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