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
Vertos mild Device Kit (MDK-0002)
Vertos Medical, Inc.
Heyman Packing Applicator Set (GM11004580)
Varian Medical Systems, Inc.
ReNew Disposable Scissor Tips
Microline Surgical, Inc.
TriMed Wrist Fixation System 3
TriMed, Inc.
Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Xenta Biomedical Science Co., Ltd.
LIAISON PLEX Yeast Blood Culture Assay
Luminex Corporation
Nightwear Aligners
Smylio, Inc.
Intense Pulse Light Therapeutic Apparatus
Shenzhen Greatro Electronic Technology Co., Ltd.
Palm NRG cellulite body device (model: Palm NRG body device)
Heat IN A Click, LLC
ZEN-2090 Turbo
Genoray Co., Ltd.
Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
Zhenjiang Assure Medical Equipment Co., Ltd.
Arthrex Spine Endoscope
Arthrex, Inc.
Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves
Hycare International Co., Ltd.
DUO1 and DUO2
Zinnovi, Inc.
Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
Olympus Medical Systems Corp.
ZIRCONOMER P
Shofu Dental Corporation
Disposable Endoscope Injection Needle
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
Hiossen, Inc.
HemoScreen Hematology Analyzer
Pixcell Medical Technologies
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary Care Diagnostics
STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
Tsk Laboratory International Japan KK
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL
Thermo Fisher Scientific
ZQuiet Advance
Sleeping Well, LLC
CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc.
Electronic Blood Pressure Monitor
Dongguan Kangweile Electronic Technology Co., Ltd.
LOSPA TKR System
Corentec Co., Ltd.
Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules
Medtronic Sofamor Danek, Inc.
FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01
Fujifilm Corporation
electric breast pump (FZ-P8); electric breast pump (YH-P8); electric breast pump (YH-P8X)
Ningbo Youhe Electrical Appliance Technology Co., Ltd.
ArcherQA (V1.0)
Wisdom Technologies., Inc.
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