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
VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B,
Control Medical Technology, Inc. / Dba Ventiv Scientific
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
Dk Medivision Co., Ltd.
Aurie System
Cathbuddy, Inc.
PureLift Pro Max
Xtreem Pulse, LLC
Uni-FuZe-C Bone Strip
Zavation Medical Products, LLC
ECHELON Synergy V10.0
FUJIFILM Healthcare Americas Corporation
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blo
Shenzhen AOJ Medical Technology Co., Ltd.
PanopticAI Vital Signs
PanopticAI technologies Limited
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
Medtronic Sofamor Danek USA, Inc.
Elite Biomedical Solutions Dose Request Cord
Elite Biomedical Solutions
IWD-Gel
InnovaCorium, Inc.
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
Blue Sky Bio, LLC
OW100S
Softwave/Trt, LLC
Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))
Guangdong Youmeng Electrical Technology Co., Ltd.
Huxley SANSA Home Sleep Apnea Test (1000-00)
Huxley Medical
Shoulder Soft Tissue Anchors
Signature Orthopaedics Pty, Ltd.
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Kdi Med Supply
Procise ADL
Procisedx, Inc.
Hexanium PLIF
Spinevision, S.A.S.
Onera Sleep Test System (Onera STS)
Onera B.V.
Disposable Intermittent Catheter (TPU Catheter)
Chengdu Daxan Innovative Medical Tech. Co., Ltd.
Paltop Narrow Implant
Paltop Advanced Dental Solutions, Ltd.
PreXion3D Expedition
Prexion Corporation
OW100S
Softwave/Trt, LLC
aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
Carlsmed, Inc.
Blue Nitrile Examination Gloves Powder Free
Amazing Rubber Products Pvt, Ltd.
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
Livsmed, Inc.
Sight OLO
S.D. Sight Diagnostics , Ltd.
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
Persyst Development Corporation
ASTar BC G- Kit
Q-Linea AB
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