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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