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
D²RS and D²RS 9090
Stephanix
Cleerly Plaque
Cleerly, Inc.
Anika Tissue Tack Fixation System
Anika Therapeutics, Inc.
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10
Ethicon Endo Surgery, LLC
TENSOR® Suture Button System
Globus Medical, Inc.
Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoje
Cardinalhealth
Eonis SCID-SMA kit
Perkinelmer, Inc.
The Circadia C300 System (C300)
Circadia Health, Inc.
Invisalign System
Align Technology, Inc.
Plato 17 Microcatheter
Scientia Vascular, Inc.
BONHAWA Respiratory Humidifier
Telesair, Inc.
Extraction Basket
Micro-Tech (Nanjing) Co., Ltd.
Tyber Medical Anatomical Plating System
Tyber Medical, LLC
Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer
Wenzhou Longwan Medical Device Factory
SeaSpine 7D Navigation Instruments
SeaSpine Orthopedics Corporation
Disposable Surgical Gown, Disposable Reinforced Surgical Gown
Fugou County Shenxiang Manufacturing Co., Ltd.
Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA4
Dongguan Boyuan Intelligent Technology Co.,Ltd
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
Innovative Health, LLC
BRM TOOL Screws, BIOPLAN Subtalar Implant
Brm Extremities
MySegmenter (v2.0.0)
Mysegmenter Technologies, Inc.
Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series
Liaoning Upcera Co., Ltd.
EmbraceMini
Empatica S.r.l.
35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS S
Winner Medical Co., Ltd.
VacHeal Negative Pressure Wound Therapy System
VacHeal, LLC
Transducer Probe Cover
Hony Medical Co., Ltd.
Cala kIQ
Cala Health, Inc.
Joylux Intimacy Gel (PG3100)
Joylux, Inc.
Electric Wheelchair (DH01126)
Foshan Dahao Medical Technology Co., Ltd.
Silver Gelling Fiber Dressing
Winner Medical Co., Ltd.
CCBIO ASCPO Needle
Cc Biotechnology Corporation
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