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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

DT100 Digital Thermometer

Smart Technology Co., Ltd.

T2

Osstem Implant Co., Ltd.

Intraoperative Ultrasound Probe Cover

Exact Medical Manufacturing

Hailie Sensor NF0110

Adherium (Nz), Ltd.

BruxZir NOW

Prismatik Dentalcraft, Inc.

BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes

Becton, Dickinson and Company

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co., Ltd.

ZSFab Lumbar Interbody System

Zsfab, Inc.

VS3-Iridium System (VS3-IR)

Visionsense, Ltd.

Endoscope Model EG-580UT and Endoscope Model EG-580UR

Fujifilm Corporation

ArtiSential Laparoscopic Instruments-Electrodes

Livsmed, Inc.

Atellica CH Diazo Total Bilirubin (D_TBil)

Siemens Healthcare Diagnostics, Inc.

Miro3D Wound Matrix

Reprise Biomedical, Inc.

AllTest Fentanyl Rapid Test (Urine)

Hangzhou AllTest Biotech Co., Ltd.

Savvy Mask - Level 3 Surgical Face Mask

Texas Medplast, LLC

Cito CBC System

Cytochip, Inc.

Toro 88 Superbore Catheter

Toro Neurovascular, Inc.

Hinscope

Hinlab Sas

ArthroFree Wireless Surgical Camera System

Lazurite Holdings, LLC

HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

AMF TT Cones

Lima Corporate S.P.A.

Welch Allyn Connex Central Station

Welch Allyn, Inc.

Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+

Magstim Company, Ltd.

YSIO X.pree

Siemens Medical Solutions

Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc.

Elecsys Anti-HBc II

Roche Diagnostics

HemosIL von Willebrand Factor Antigen

Instrumentation Laboratory CO

FlowArt® Needle-Free Split Septum Valve

Asset Medikal Tasarim San Tic As.

LARALAB

Laralab GmbH

KeriFlex® MCP and PIP Finger Joint Prostheses

Keri Medical SA

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