510(k) Device Clearances

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

Lotuxs Medtech (Suzhou) Co., Ltd.

AccuContour

Manteia Technologies Co., Ltd.

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

Foshan Coxo Medical Instrument Co., Ltd.

B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

B.R.A.H.M.S GmbH, Part of Thermo Fisher

FACE4D Aligner

Avinent Implant System S.L.U.

TimeWaver Frequency

Timewaver Production GmbH

Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and No

Nobel Biocare AB

Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)

Olympus Medical Systems Corporation

AI Platform 2.2 (AIP002)

Exo Imaging

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

Stryker Endoscopy

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire G

Olympus Medical Systems Corp.

Vesseal

Lydus Medical , Ltd.

Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)

SteriLance Medical (Suzhou), Inc.

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

Megagen Implant Co., Ltd.

Access NT-proBNP

Beckman Coulter, Inc.

Electrically powered wheelchair

Kunshan Hi-Fortune Health Products Co., Ltd.

eXaSkin Plus

Anatomical Geometry S.L.

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

Tosoh Bioscience, Inc.

Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pul

Hangzhou Ruidi Biotechnology , Ltd.

BioBrace ® RC Delivery System

Conmed Corporation

Pro M Class

Saeyang Microtech Co., Ltd.

Mobility Scooter (X-12, X-14, X-17)

Wuyi Aichi Industry and Trade Co., Ltd.

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM T

Inomed Medizintechnik GmbH

Cala kIQ

Cala Health, Inc.

AcQMap High Resolution Imaging and Mapping System

Acutus Medical, Inc.

dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16

Philips Medical Systems Nederland B.V.

Molecular Flow Simulations

Therataxis, LLC

Aerogen Pro-X1 Controller System

Aerogen, Ltd.

Filter Needle for Single Use

Hangzhou Qiantang Longyue Biotechnology Co., Ltd.

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)

Olympus Medical Systems Corporation