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
ClotTriever XL Catheter (41-102)
Inari Medical, Inc.
EXALT Model B Single-Use Bronchoscope
Boston Scientific Corporation
Wireless Digital Flat Panel Detector
Iray Technology Taicang , Ltd.
Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter
Abbott
ReVISION 2
Argus Cognitive, Inc.
HealthFLD
Nano-X AI , Ltd.
Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/
SeaSpine Orthopedics Corporation
Smart Correction System (HA Half Pins)
Wishbone Medical, Inc.
Tacrolimus Assay Kit
Shanghai Genext Medical Technology Co., Ltd.
Arthrex Elbow Fracture Plating System
Arthrex, Inc.
Multi-parameter detector
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
Puritan PurSafe Plus Collection and Transport System
Puritan Medical Products, LLC
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
Shenzhen Sungrow Led Technology Co., Ltd.
REMI Remote EEG Monitoring System
Epitel, Inc.
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
Biofire Diagnostics, LLC
G7® Acetabular System
Zimmer Biomet
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
Integra LifeSciences Corporation
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue;
Sri Trang Gloves Thailand (Public Company Limited)
Motive Muscle Stimulator for Lower Back (OT01-1003)
Motive Health, Inc.
IPS e.max Zirconia
Ivoclar Vivadent, Inc.
Tissue Approximation System
Tas Medical, Inc.
Viveve 2.0 System
Viveve, Inc.
Cydar EV (Series B) and Cydar EV Maps
Cydar , Ltd.
Sterilization Wraps
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
10THERMA
Tentech, Inc.
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
The Binding Site, Ltd.
Surgical Mask
Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.
SKR 3000
Konica Minolta, Inc.
Ideal Med Pro 3-Ply Disposable Face Mask
Jsn Holdings, LLC
Xpert Hand
Newclip Technics
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