RecallHawk

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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