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
Revolution Ascend
Ge Healthcare Japan Corporation
Disposable Sterile Syringe
Weihai Shengjie Medical Technology Co., Ltd.
TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
Hong Qiangxing (Shenzhen) Electronics Limited
Auxilock GFS Mini, GFS II Large, and GFS Ultimate
Auxein Medical Private Limited
SmartCardia 7L Platform (MCT)
Smartcardia SA
Dia-X Bond Universal
DiaDent Group International
Lancing device (HH-XV-T)
Tianjin Huahong Technology Co., Ltd.
Nonin OTC Pulse Oximeter Model 3250
Nonin Medical, Inc.
PathLoc Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd.
Neuronaute Plus
Bioserenity Sas
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
Barbaras Development, Inc.
70 NeuGlide Catheter
Piraeus Medical, Inc.
Volnewmer
Classys, Inc.
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Vivid T9/Vivid T8
GE Medical Systems Ultrasound and Primary Care Diagnostics
Med-link Disposable ECG Cable and Leadwires
Shenzhen Med-Link Electronics Tech Co., Ltd.
TriSalus TriNav Advance Infusion System
Trisalus Life Sciences
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-30
Shenzhen Osto Medical Technology Co.,Ltd
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Edan Instruments, Inc.
MDx-Chex for BC-GN
Streck
Amydi-med Disposable Non-invasive EEG electrodes
Shenzhen Amydi-Med Electrics Tech Co., Ltd.
Ceribell Delirium Monitor System
Ceribell, Inc.
BLESSING System
Cellah Medical Co., Ltd.
Ventana A Anterior Lumbar Interbody System
Spinal Elements, Inc.
AffloVest® Mobile Airway Clearance Therapy
Tactile Medical
PAL Sterilization Case
Microaire Surgical Instruments, LLC
IPL Hair Removal Device, model: AI01
Shenzhen Century Dongyuan Technology CO , Ltd.
Demi Pro
Meta Systems Co., Ltd.
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
Avia Vascular
Stable-C Interbody System
Nexus Spine, LLC
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