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
OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct
Riverpoint Medical, LLC
Fiber Laser Treatment Systems (HS-232,HS-233)
Shanghai Apolo Medical Technology Co., Ltd.
Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/
SeaSpine Orthopedics Corporation
VitroPRO
CIVCO Medical Instruments Co., Inc.
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
Nobel Biocare AB
Cardiac Workstation (5000); Cardiac Workstation (7000)
Philips Medizin Systeme Böblingen GmbH
Denture Base Resin
Aidite (Qinhuangdao) Technology Co., Ltd.
AI-Rad Companion Prostate MR
Siemens Healthcare GmbH
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Med
Pentax of America, Inc.
KLS Martin Ixos System
KLS Martin L.P.
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
Apex BioTechnology Corp.
FemChec Controlled Saline-Air Device (FCD-250)
Femasys, Inc.
Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
Wishbone Medical, Inc.
Virgo Mobility Scooter (Virgo-D,Virgo-F)
Jiangsu Intco Medical Products Co., Ltd.
CHIKAI Nexus petit
Asahi Intecc Co., Ltd.
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
Olympus Medical Systems Corporation
Neonav ECG Tip Location System
Navi Medical Technologies
Capiox iCP Centrifugal Pump
Terumo Cardiovascular Systems Corporation
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
Wontech Co., Ltd.
Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc.
Evo sEEG System
Neuroone Medical Technologies Corp.
ACTIVBRAID
Embody, Inc.
Prism
Graymatters Health , Ltd.
Therapy Mask 3100 NC/SP
Respironics, Inc.
Ulike Reglow Light Therapy Device (UM10)
Shenzhen Ulike Smart Electronics Co., Ltd.
CORUS Navigation System-GN
Providence Medical Technology, Inc.
LCD Monitor (CL1902A, CL2103F)
Shenzhen Beacon Display Technology Co., Ltd.
BRM Digitalis Spacer
Brm Extremities Srl
Claria System
Claria Medical, Inc.
Discovery MI Gen2
Ge Medical Systems, LLC
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