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
Surgical Face Mask
Jiangxi Ganlong Pharmaceutical Co., Ltd.
ActiGraph LEAP activity monitor (ActiGraph LEAP)
Actigraph, LLC
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Roche Diabetes Care GmbH
AeviceMD
Aevice Health Pte. , Ltd.
Celerity Incubator
STERIS Corporation
Protective Gown AAMI Level 4
Kenpax International Limited
Axial3D Insight
Axial Medical Printing Limited
Vial Adapter
Hangzhou Qiantang Longyue Biotechnology Co., Ltd.
Atellica CH Enzymatic Creatinine_3 (ECre3)
Siemens Healthcare Diagnostics, Inc.
implantcast Packaging System Update
Implantcast GmbH
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
3M Healthcare Business Group
SafeBreak Vascular
Lineus Medical, LLC
Diode laser therapy device
Beijing Star New Tech Co., Ltd.
Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Re
Covidien, LLC
Navagio Lumbar Cage
Kalitec Medical, LLC
BrainsWay Deep TMS System
Brainsway , Ltd.
T3 Platform Software
Etiometry, Inc.
Nu-beca Transcutaneous Electrical Nerve Stimulation
Nu-Beca & Maxcellent Co.
Sonic DL
Ge Medical Systems,Llc (Ge Healthcare)
Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Bea
Conmed Corporation
ZIP MIS Interspinous Fusion System
Aurora Spine, Inc.
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
Biomerieux S.A.
ShiNeo Silicone Implant
Shineo Technology Co., Ltd.
ApneaRX Pro
Apnea Sciences Coporation
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
Safeskin Retailing (Hk) Limited
Digital Blood Pressure Monitor
Guangdong Genial Technology Co., Ltd.
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
Shenzhen Finicare Co., Ltd.
G Surgical Marksman MIS System
G Surgical, LLC
NEONA 1.5T MRI System
Time Medical Limited
SureTune4 Software
Medtronic Neuromodulation
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