510(k) Device Clearances

INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tub

Penumbra, Inc.

F&P Airvo 3 NIV (PT311US)

Fisher & Paykel Healthcare, Ltd.

NeurAxis IB-Stim (01-1020)

Neuraxis

Functional MR V1.0

Olea Medical S.A.S.

Wearable Breast Pump (Model W6)

Shenzhen TPH Technology Co., Ltd.

NB 1 SA Implant System

Arum Dentistry Co., Ltd.

Solar Compact (G4-1)

Laborie Medical Technologies, Corp.

ZircaGlow & ZircaGlow HT Zirconia

United Zirconia

HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System

Samsung Medison Co., Ltd.

ClearRead CT

Riverain Technologies, Inc.

EpilME

Neauvia North America

Metal Cannulated Screw

Double Medical Technology, Inc.

mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58

MED-EL Elektromedizinische Geräte GmbH

Arthrex Self Punching SwiveLock Suture Anchors

Arthrex, Inc.

Woo More Play Coconut Love Oil

Woo Essentials, Inc.

TOV Dental Implant System

Rdj Tov Implant, Ltd.

BTL-785MJ

BTL Industries, Inc.

Omnipod 6 algorithm

Insulet Corporation

Smart Wireless Stethoscope

Shanghai Hulu Devices Co., Ltd.

CONDUIT LLIF Straight Inserters

Enztec Limited

Spectrum IQ Infusion System with Dose IQ Safety Software

Baxter Healthcare Corporation

Ziehm Solo FD

Ziehm Imaging GmbH

Dental Zirconia Ceramic

Aidite (Qinhuangdao) Technology Co., Ltd.

CATALYSTEM Femoral Stems

Smith & Nephew, Inc.

Clear Aligner

Shenzhen Meiming Dentistry Technology Co., Ltd.

Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311

Alicn Medical Shenzhen, Inc.

Philips IntelliSite Pathology Solution 5.1

Philips Medical Systems Nederland B.V.

Lynx Aspiration Catheter System

Q’Apel Medical, Inc.

Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Maxx Orthopedics, Inc.

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G

Shenzhen AOJ Medical Technology Co., Ltd.