510(k) Device Clearances

NerivioInfinity

Theranica Bioelectronics , Ltd.

AERO MIS Facet Fusion System

Aurora Spine

ALGO Pro Newborn Hearing Screener (ALGO Pro)

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

VERTICALE® Navigation Instruments

Silony Medical GmbH

ARK Methotrexate II Assay

Ark Diagnostics, Inc.

Upper arm electronic blood pressure monitor (XB-01)

Shenzhen Ziqing Medical Equipment Co., Ltd.

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

Sorin Group Italia S.R.L.

Tracheal Stent System (Y-Shaped)

Micro-Tech (Nanjing) Co., Ltd.

ClearPoint Bone Screw Fiducials

ClearPoint Neuro, Inc.

Alinity h-series System

Abbott Laboratories

Lumos 3DX

3Dio

Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxico

Geotek Medikal Ltd Sti

I-Genius (100019400)

Esaote, S.p.A.

ProxiDiagnost N90 / Precision CRF (706110, 706400)

Philips Medical Systems Dmc GmbH

KeYi Total Knee System

Beijing Keyi Medical Device Technology Co., Ltd.

USTOMED Bone Fixation/Bone Augmentation Systems - PIN

Ustomed Instrumente Ulrich Storz GmbH & Co. KG

Procedure mask/Surgical mask/Face mask

Winner Medical Co., Ltd.

OsteoFlo HydroFiber

SurGenTec, LLC

DRX-Revolution Mobile X-ray System

Carestream Health, Inc.

Nordica PV Cryo Mapping Catheter

Synaptic Medical Corporation

Powder Free Nitrile Examination Gloves Non-Sterile Black

Kanglongda Vietnam Protection Technology Company Limited

Sure-Fine Insulin Syringes

Shina Med Corporation

CRYOcheck Chromogenic Factor IX

Precision Biologic, Inc.

17HQ701G-B

Lg Electronics.Inc

RW-1

Mediott, Inc.

Invisalign System, Pre-Formed Attachment System

Align Technology, Inc.

Radiance V5

Gmv Soluciones Globales Internet S.A.U.

Quell-FM

Neurometrix, Inc.

Lung AI (LAI001)

Exo, Inc.

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Linshom Medical, Inc.