510(k) Device Clearances

Masimo W1

Masimo Corporation

MiVu™ Esophageal Endo Cap

Diversatek Healthcare

Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapL

Vascular Solutions, LLC

neoLaser Laser Surgery Fibers

G.N.S Neolaser , Ltd.

Neuronaute Plus

Bioserenity Sas

Osstem Implant System

Osstem Implant Co., Ltd.

Korotkoff sound blood pressure monitor

Beijing Hanvon Health Technology Co., Ltd.

HardyDisk AST Cefiderocol 30µg (FDC30)

Hardy Diagnostics

Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003

Relign Corporation, Subsidiary of Zimmer Biomet

CELERITY HP Indicator Tape

Steris

LumenCare Azure

Nucletron B.V.

Med-link Disposable ECG Cable and Leadwires

Shenzhen Med-Link Electronics Tech Co., Ltd.

Q2 Blood Administration Sets

Quest Medical, Inc.

Fast PCR Mini Respiratory Panel

Autonomous Medical Devices Incorporated

SV600, SV800 Ventilator

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

TENSWave

Zynex Medical Officer

MAC 7 Resting ECG Analysis System

Ge Medical Systems Information Technologies, Inc.

Paradigm System

Proprio, Inc.

i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)

I3 Membrane GmbH

Esthetic Abutments Nobel Biocare N1

Nobel Biocare Services AG

i-STAT CG8+ cartridge with the i-STAT 1 System

Abbott Point of Care, Inc.

VALO X, VALO X Accessory Lenses

Ultradent Products, Inc.

SPECTRUM® GV Bone Cement

Osteoremedies, LLC

Wolff's Law Anterior Cervical Plate System

Spinal Simplicity, LLC

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Gentuity, LLC

Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

AccelFix Lumbar Expandable Cage System

L&K BIOMED Co., Ltd.

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)

Becton, Dickinson and Company

Genesis Sleep

Neurofield, Inc.

TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wri

TriMed, Inc.