510(k) Device Clearances

Q Guidance System; Mako Spine System;

Stryker Leibinger GmbH & Co KG

CIRCUL8 Luxe DVT Prevention Device

Ortho8, Inc.

AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup

Hangzhou AllTest Biotech Co., Ltd.

3D-SHAPER

3D-Shaper Medical S.L

Remunity 2.0 Pump for Remodulin (treprostinil) Injection

Deka Research and Development Corp.

InterSpace GV Hip Spacer

Tecres S.P.A.

iRAD

Claritas Healthtech Pte, Ltd.

G aenial Universal Injectable II

GC America, Inc.

Remunity System

Deka Research and Development

Sensatronic Reusable Temperature Probes

Sensatronic GmbH

LFR-260

Evolution Optiks Limited

ZenPro 40

BLUECORE COMPANY Co., Ltd.

eZSURE™ Empty Fluid Container

Epic Medical Pte. , Ltd.

ScleroSafe™ 150 mm, ScleroSafe™ 350 mm

Vvt Medical , Ltd.

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonosco

Pentax of America, Inc.

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

Ellex Medical Pty, Ltd.

Optimas MAX System

InMode , Ltd.

Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)

Terragene S.A.

HS Fiber

Riverpoint Medical

VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack

Ortho Clinical Diagnostics

Neonav ECG Tip Location System

Navi Medical Technologies

Contour ProtégéAI

Mim Software, Inc.

tmCMF Solution

Techmah Cmf

Exo Iris

Exo Imaging, Inc.

BinaxNOW™ COVID-19 Antigen Self Test

Abbott Diagnostics Scarborough, Inc.

RTapp

Segana, Inc.

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

Alicn Medical Shenzhen, Inc.

Dynamic TiBase

Talladium España, SL

HemoSphere Nano Monitor (HSNANO1)

Edwards Lifesciences, LLC

ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 1

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.