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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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