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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