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
UV Smart D60
UV Smart Technologies B.V.
PRIMED Pediatric Facemask
Primed Medical Products, Inc.
Transcutaneous Electrical Nerve Stimulator (K6106)
Shenzhen Yicai Health Technology Co., Ltd.
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder);
Kamemizu Chemical Industry Co., Ltd.
Dynamis Pro Family
Fotona D.O.O.
Medical surgical mask
Guangdong Kingfa Sci. & Tech.Co., Ltd.
Accuro® 3S Needle Guide Kit
Rivanna Medical, Inc.
StitchKit
Origami Surgical Inc .
PIUR tUS inside
Piur Imaging GmbH
ACR Screw System
Biomaterials Korea, Inc.
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Luliang Hongruida Health Protection Technology Co., Ltd.
Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses
Acuity Polymers, Inc.
Extra Silver Gelling Fiber Dressing
Winner Medical Co., Ltd.
AltiVate® Anatomic Shoulder AG e+ with Markers
Encore Medical L.P.
OsteoProbe
Active Life Scientific, Inc.
Suction Pump (SU-90)
Shenzhen HugeMed Medical Technical Development Co., Ltd.
PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System
Stryker GmbH
Aperio GT 450 DX
Leica Biosystems Imaging, Inc.
Access Thyroglobulin
Beckman Coulter, Inc.
Tyto Insights for Rhonchi Detection
Tyto Care , Ltd.
Medical Nitrile Examination Gloves
Jiangxi Ronglai Medical Technology Co., Ltd.
Perceptive electric dental motor and control unit
Lares Research
Eminent Spine 3D Lumbar Interbody Fusion Systems
Eminent Spine, LLC
Patient Specific Planning Solution 3D Bone Models
Biomet Manufacturing Corp
Aptiva APS IgA Reagent
Inova Diagnostics, Inc.
DenMat Glutaraldehyde Desensitizer
Denmat Holding, LLC
Curian Campy
Meridian Bioscience, Inc.
NeuroSwift Pro
Neurobit Technologies Co., Ltd.
Samsung ECG App v 1.3 (ECG)
Samsung Electronics Co., Ltd.
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Cathete
Medsource International, LLC
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