510(k) Device Clearances

NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-

Raumedic AG

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERIT

Spectrum Dynamics Medical, Ltd.

SafeBreak® Vascular

Lineus Medical

XERO-alpha

DRTECH Corporation

RADIANCE ULTRA 32 4K ZEROWIRE DUO

Nds Surgical Imaging, LLC

DISINTEK™ PA Test Strips

Serim Research

Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

Shenzhen AOJ Medical Technology Co., Ltd.

ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

Anumana, Inc.

Identify (4.0)

Varian Medical Systems, Inc.

DuraPro™ Oscillating System

Globus Medical, Inc.

Unity Total Knee System

Corin U.S.A. Limited

TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

Hong Qiangxing (Shenzhen) Electronics Limited

Momentum Spine

Momentum Health, Inc.

Stryker MP, Mandible, HMMF and MMF AXS Screws

Stryker Leibinger GmbH & Co KG

True Tulip, True M.I.S.

Innovative Surgical Designs, Inc.

17HQ901G-B

Lg Electronics.Inc

Atalante

Wandercraft SAS

HemosIL von Willebrand Factor Antigen

Instrumentation Laboratory CO

Ortho MI System

Osteonic Co., Ltd.

ES1 System

E-Scopics

EchoGo Amyloidosis (1.0)

Ultromics Limited

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

Karl Storz SE & CO. KG

Magnetic Surgical System

Levita Magnetics International Corp

Easycess Aspiration Pump

Guangzhou Easycess Medical Co.,Ltd

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

Ambu A/S

WebCeph

Assemblecircle Corp.

GoLIF! Lumbar Interbody Fusion System

Getset Surgical, SA

Swoop Portable MR Imaging System

Hyperfine, Inc.

Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fu

Spinal Simplicity, LLC

Estremo Fibular Nail

Citieffe S.R.L.