510(k) Device Clearances

BENCOX Mirabo Cup System

Corentec Co., Ltd.

Light Therapy Mask (1019055)

Merchsource, LLC

DORA Disposable A.V. Fistula Needle Sets

Bain Medical Equipment (Guangzhou) Co., Ltd.

Carpentier-Edwards Physio Annuloplasty Ring (4450)

Edwards Lifesciences, LLC

Kii Structural Balloon Access System

Applied Medical Resources Corp.

Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)

Spectrum Medical S.R.L.

Access anti-HBc IgM

Beckman Coulter, Inc.

Béa Applicator (BAP-GB-01)

Stepone Fertility Ltd (T/A Béa Fertility)

Venue Go

GE Medical Systems Ultrasound and Primary Care Diagnostics

Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04);

Avanos Medical, Inc.

restor3d Pin Implants

Restor3D

BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device

Becton, Dickinson and Company

Self-adhesive Electrode

Guangdong Comytens Medical Technology Co., Ltd.

Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit

Stryker Corporation

FilmArray Pneumonia Panel plus

Biofire Diagnostics, LLC

Colibrí

Copan Wasp Srl

Straumann Surgical Cassettes

Straumann USA, LLC

XOD Diathermia Radiofrequency Device

Xod, Inc.

Cleerly ISCHEMIA

Cleerly, Inc.

Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)

Shenzhen Dongjilian Medical Tech Co., Ltd.

Bullsai

Turing Medical Technologies, Inc.

nordicAudio (1.0)

Nordicneurolab AS

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

Ra Medical Systems,Inc

Microwave Ablation Device

Nanjing Dewen Medical Technology Co., Ltd.

Nano-Check™ COVID-19 Antigen Test

Nano-Ditech Corporation

Genesys Spine Sacroiliac Joint Fusion System with Navigation

Genesys Spine

Epicardial Access System

Baylis Medical Company, Inc.

Atellica® CH Creatinine_3 (Crea3)

Siemens Healthcare Diagnostics, Inc.

Respond OC Conserving Regulator (130-0800)

Responsive Respiratory

Signature™ ONE System

Orthosoft Inc. (d/b/a) Zimmer CAS