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
Suture-TOOL System
Suturion AB
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD
DRTECH Corporation
Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
360CAS Knee
Kico Knee Innovation Company Pty, Ltd.
Unipro (K-UNIPRO-US)
Tenscare, Ltd.
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
Cardinalhealth
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (O
Shenzhen Vitavitro Biotech Co., Ltd.
JARVIS Glenoid Reverse Shoulder Prosthesis
FH Industrie
FORUM
Carl Zeiss Meditec, AG
Zirconia Block
Hunan Hualian Special Ceramics Co., Ltd.
Resitu Slider 09 (RESL09)
Resitu Medical AB
Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)
Anhui Happiness Workshop Instruments Co., Ltd.
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
Shenzhen Beacon Display Technology Co., Ltd.
EchoConfidence (USA)
Mycardium AI Limited
Invictus® Bone Cement, Invictus Spinal Fixation System
Alphatec Spine, Inc.
GyriCalc (Version 1.0.0)
Neurospectrum Insights Corp.
SAVE GBR
Dentis Co., Ltd.
BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-
MacroLux Medical Technology Co., Ltd.
Access Rubella IgG
Beckman Coulter, Inc.
GM85
Samsung Electronics Co., Ltd.
LimFlow Vector
LimFlow, Inc.
Blue Topaz Sacroiliac Screw System
Osseus Fusion Systems, LLC
Customize
3D-Side S.A.
TiLink-L SI Joint Fusion System
SurGenTec, LLC
Simparo Anchor Line Fixation System
Simparo, Inc.
Titan Dental Design
Clearadvance, LLC
Silver Fluoride Hypersensitivity Varnish
Young Dental Manufacturing Co. 1, LLC
GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
Glove One, LLC
Profoject Safety Sliding Blood Collection Set
CMT Health PTE., Ltd.
HS Fiber Cerclage
Riverpoint Medical, LLC
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