510(k) Device Clearances

VASSALLO GT EXT

Filmecc Co., Ltd.

MIM – Dose Analysis

Mim Software, Inc.

Venera 608 Deep Vein Thrombosis (DVT) Prevention System

Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

F88 URE-SD/RD Flexible Ureteroscope

Sg Endoscopy Pte, Ltd.

InnovaMatrix PD

Triad Life Sciences, Inc.

EnCor EnCompass™ Breast Biopsy and Tissue Removal System

Bard Peripheral Vascular, Inc.

AcQMap High Resolution Imaging and Mapping System

Acutus Medical, Inc.

Klockner Abutments

SOADCO, S.L.

Arthrex Knotless FiberTak Suture Anchor

Arthrex, Inc.

VERIFY STEAM Integrating Indicator

STERIS Corporation

Cala kIQ

Cala Health, Inc.

Evolve Nitric Oxide Delivery System

Mallinckrodt Manufacturing, LLC

B4C System - Addition of new sensor model (BcSs-PICNIW-2000)

Braincare Desenvolvimento E Inovação Tecnológica S.A.

EnteraLoc Flow

Vonco Products

DS Implants abutments provided with the EV connection

Dentsply Sirona

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Zeus Scientific

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid

Prevest Denpro Limited

Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

Sleepnet Corporation

LED Lip Perfector, model: ZC-05

Light Tree Ventures Europe B.V.

Equinoxe® Shoulder System

Exactech, Inc.

ICON 35; ICON 45; ICON 60; ICON 30FAF

Rehasense USA, Inc.

Blood Pressure Monitor (W06LT)

Shenzhen Jamr Technology Co., Ltd.

Endo Motor

Shenzhen Perfect Medical Instruments Co., Ltd.

SureCath Set

Coloplast Corp.

Second Opinion® Panoramic

Pearl, Inc.

Ultimate rTMS for OCD (M-series)

Brain Ultimate, Inc.

Disposable Belts for Polysomnography (CNSAC)

CNSAC Medshop GmbH

Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR

Fujifilm Corporation

Visualase V2 MRI-guided Laser Ablation System (9736422)

Medtronic Navigation

Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses

Pegavision Corporation