510(k) Device Clearances

Biotres

Biotricity

BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube

Becton, Dickinson and Company

Extremity Medical External Fixation System

Extremity Medical, LLC

SaliPen

Saliwell , Ltd.

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization Sy

Steris

Angled Abutment

Arum Dentistry Co., Ltd.

XVbeam2000

Shenzhen Xpectvision Technology Co., Ltd.

Resilience Fully Covered Esophageal Stent System

Merit Medical Systems, Inc.

Neurolyser XR (NXR100)

Fusmobile, Inc.

Cadence Ankle PSI System

3D Systems, Inc.

FAQ™ 201, FAQ™ 202

Foreo, Inc.

Anti Grinding Guard

Xiamen Yizhou Imp. & Exp. Co., Ltd.

Critical Care Suite with Enteric Tube Positioning AI Algorithm

Ge Medical Systems, LLC

uEXPLORER

Shanghai United Imaging Healthcare Co., Ltd.

Reveal LINQ Insertable Cardiac Monitor

Medtronic, Inc.

Wearable Digital Thermometer (T31)

Guangdong Genial Technology Co., Ltd.

Electric Wheelchair (HG-630)

Zhejiang Automwheel Tech Co., Ltd.

Lucitone Digital Print Denture System

Dentsply Sirona

c1Trac

Zimmer Medizinsysteme GmbH

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

Ambu A/S

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

B.T.I. Biotechnology Institute, Sl.

PAO Cortical Screw

Medacta International S.A.

dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coil

Invivo Corporation

SmoothSkin Pure Unplugged (SSB3)

Cyden Limited

IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32

Shenzhen Yangyi Technology ., Ltd.

NeurAxis IB-Stim (01-1020)

Neuraxis

GPS Advanced; 5 cc GPS Advanced Cannula

Prosidyan, Inc.

uDR 380i Pro

Shanghai United Imaging Healthcare Co., Ltd.

QuickAligners

Oral Image, Inc.

SMILERS

Biotech Dental Smilers, Sas