510(k) Device Clearances

HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water ba

Maxigen Biotech, Inc.

LARS ACJ

Movmedix S.A.S.

eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy Wearable Breast Pump E10 (T8D03) Model T8D03; eufy Wearable Breas

Shenzhen TPH Technology Co., Ltd.

CORE-SNARE

Incore Co., Ltd.

NeoPEX™ Pre-Mixed Obturation Paste

NuSmile, Ltd.

SpaceOAR Flex™ System

Boston Scientific Corporation

Benesta Tissue Removal Device

Caldera Medical, Inc.

Hemoclip

Hangzhou AGS MedTech Co., Ltd.

P200TE (A10700)

Optos Plc.

Upper Arm Electronic Blood Pressure Monitor

Shenzhen Goodlymed Technology Co., Ltd.

CARTO™ 3 EP Navigation System V8.1

Biosense Webster, Inc.

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

OEC One CFD

Ge Hualun Medical Systems Co. , Ltd.

RCT600

Ray Co., Ltd.

ZEUS System (Zio Watch)

iRhythm Technologies, Inc.

Aventus Thrombectomy System

Inquis Medical

ICS Dizcovery (1091)

Natus Medical Denmark Aps

Invisalign System

Align Technology, Inc.

SimplGuide

Pendracare

HotDog Warming Mattress + Return Electrode

Augustine Temperature Management, LLC

V-DAC Catheter

Vesalio, Inc.

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

Lina Medical Aps

EMBOLD™ Soft Detachable Coil System

Boston Scientific Corporation

DUO1 and DUO2

Zinnovi, Inc.

PISCES-SA Standalone ALIF Interbody System

Osseus Fusion Systems

Arthrex TightRope Soft Button, RT

Arthrex, Inc.

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test M

Assure Tech., LLC

DB 4000 High Impact Denture Base

Carbon, Inc.

Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

Encompass Industries Sdn. Bhd.