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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

Oxy2Pro

Southmedic, Inc.

Liv Pre-lubricated Intermittent Catheter

HR Healthcare

Neodent Implant System - Zirconia Implant System

JJGC Indústria e Comércio de Materiais Dentários S.A.

CavaClear Laser Sheath

Spectranetics, Inc.

FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F000

Fresenius Medical Care Renal Therapies Group, LLC

Access Testosterone

Beckman Coulter, Inc.

DeltaScan Monitor

Prolira B.V.

Galaxy System

Noah Medical Corp.

Ecomed Disposable Administration Sets

Ecomed Solutions, LLC

Sterile Surgical Powder Free Latex Glove

New Era Medicare Sdn. Bhd.

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd.

MULTIX Impact, MULTIX Impact C

Siemens Medical Solutions USA, Inc.

Vital Signs Monitor

Beijing Choice Electronic Technology Co., Ltd.

OptiMap Catheter - 60mm (OPTI-CATH2-60)

Cortex, Inc.

LOGIQ E10s

GE Medical Systems Ultrasound and Primary Care Diagnostics

Xpert Hemorrhagic Fever

Cepheid

LightWalker Laser System Family

Fotona D.O.O.

VEEGix EEG System

NeuroServo, Inc.

Disposable Powder Free Polyethylene Examination Gloves

Mastermax Plastic (Huizhou), Ltd.

Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

Baxter Healthcare Corporation

Stable-C Interbody System

Nexus Spine, LLC

CINA-VCF

Avicenna.Ai

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

Perfect Medical Industry (Vn) Co., Ltd.

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee

Orthalign, Inc.

Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Singl

Henan Nursecare Biotechnology Co., Ltd.

Ceftobiprole BPR 5 µg Disc

Liofilchem, Inc.

SPIFE A1AT kit

Helena Laboratories, Corp.

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

Philips Ultrasound, LLC

ZYLOX Hippo PTA Balloon Dilatation Catheter

Zylox Medtech Co., Ltd.

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