510(k) Device Clearances

EASYMADE-TI

CG Bio Co., Ltd.

InMode System with the Morpheus8 90 Applicator

InMode , Ltd.

Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff,

Summit Glove, Inc.

Composite Orthodontic Brackets and Buttons

Ec Certification Service GmbH

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

Sorin Group Italia S.R.L.

Axon Therapy

Neuralace Medical, Inc.

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

Thermo Fisher Scientific

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)

Ultrasound Biotechnology (Shanghai) Co., Ltd.

Conformity Stem Extension Line

United Orthopedic Corporation

Resolve Fundus Camera

Optain Health, Inc.

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

Life Technologies Corporation

BruxZir® Esthetic NOW

Prismatik Dentalcraft, Inc.

Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

Stryker Sustainability Solutions

Chemfort Female Luer Lock Adaptor

Simplivia Healthcare , Ltd.

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio

Fujirebio Diagnostics,Inc.

Dermal Cooling System

R2 Technologies, Inc.

SMR Stemless Anatomic

Lima Corporate S.P.A.

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Signifier Medical Technologies, Ltd.

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio

Ultradent Product, Inc.

EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)

Stemcell Technologies Canada, Inc.

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

bioMerieux, Inc.

MEBO Wound Dressing

Mebo Life Science, Inc.

Mother's Nature W1 Warming Wearable Breast Pump

Shenzhen TPH Technology Co., Ltd.

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalba

Thermo Fisher Scientific

Tyto Insights for Eardrum Bulging Detection

Tyto Care , Ltd.

F&P Solo Mask Range

Fisher & Paykel Healthcare, Ltd.

14F iSLEEVE™ Introducer Set

Boston Scientific Corporation

DynamicIQ

GE Medical Systems SCS

Sterile Hypodermic Needles for Single Use

Zhejiang Kindly Medical Devices Co., Ltd.

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

Bausch and Lomb, Incorporated