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
EMBOTRAP III Revascularization Device
Neuravi, Ltd.
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No.
Abbott Molecular, Inc.
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
Thermo Fisher Scientific
Disposable Surgical Mask
Heilongjiang Yinjia Medical Equipment Co., Ltd.
Firefighter NC Pro PTCA Balloon Catheter
Shanghai MicroPort Medical (Group) Co., Ltd.
ARIX Small Fragment System
Jeil Medical Corporation
PHAROS
Brightonix Imaging
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd.
SmartSpectra Vital Signs Monitor 1.0
Presage Security, Inc. d/b/a Presage Technologies, Inc.
Donagamex Blue Performance Protective Gown
Dong Nai Garment Corporation (Donagamex)
MCB UNIT Model: V10GMCBUS
Lamidey Noury Medical
SterileRight sterilization pouch and roll
Sterileright Packaging Mfg., Inc.
Zio® monitor (DFG0001)
iRhythm Technologies, Inc.
Medical Face Mask
Hubei Medlink Healthcare Co., Ltd.
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Artix Thrombectomy Device
Inari Medical
Medical Gloves
Beijing Biosis Healing Biolog Ical Technology Co., Ltd.
LumiVy Lumbar IBF System
Vy Spine, LLC
Digital Thermometer (Model QT001)
Shen Zhen Rong Feng Technology Co., Ltd.
Procedure mask/Surgical mask/Face mask
Winner Medical Co., Ltd.
Sterile Posterior Spinal Fixation System
Shanghai Reach Medical Instrument Co, Ltd.
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and N
Sri Trang Gloves (Thailand) Public Company Limited
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
Tosoh Bioscience, Inc.
BD BACTEC Plus Aerobic/F Culture Vials
Becton, Dickinson and Company
Masimo Stork
Masimo Corporation
Belun Sleep System BLS-100
Belun Technology Company Limited
Xerxes Hip Stem
Xerxes Arthopedix, LLC
Prodeon Urethral Sheath System
Prodeon Medical, Inc.
Bio-Medicus Life Support Catheter and Introducer
Medtronic, Inc.
Selectra Lead Implantation System
Biotronik, Inc.
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