510(k) Device Clearances

Spark™ Clear Aligner System

Ormco Corporation

Electric Nasal Aspirator (BC026, BC025, BC023)

Shenzhen Kingboom Technology Co., Ltd.

FiAPC plus probes

Erbe Elektromedizin GmbH

Integral Titanium Cervical Interbody

Nvision Biomedical Technologies, Inc.

Eclipse Blood Collection Set

Eclipse Medcorp, LLC

Surgical Face Masks (Ear Loops And Tie-On)

San-M Package Co., Ltd.

da Vinci Surgical System, Model IS5000

Intuitive Surgical, Inc.

MX50N

Wide Corporation

IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories

Ipg Medical Corporation

Alere NT-proBNP for Alinity i Reagent Kit

Axis-Shield Diagnostics, Ltd.

OTS Hip

Ortoma AB

Pre-Formed Penile Silicone Block

International Medical Devices, Inc.

Lilliput APD System

Fresenius Medical Care Renal Therapies Group, LLC

Scivita 4KINSIGHT ICG Imaging System

Scivita Medical Technology Co., Ltd.

RADx Intraoral Appliance for Snoring and Sleep Apnea

Achaemenid, LLC

Kodiak Lumbar Spacer System

Met One Technologies, LLC

BinaxNOW COVID-19 Ag Card

Abbott Diagnostics Scarborough, Inc.

BriefCase

Aidoc Medical , Ltd.

Tablo Hemodialysis System

Outset Medical, Inc.

OmniTom Elite

Neurologica Corporation, A Subsidiary of Samsung

Baby Gorilla/Gorilla Plating System; Monster Screw System

Paragon 28, Inc.

Dexcom G7 Continuous Glucose Monitoring System

Dexcom, Inc.

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II

Remex Medical Corp.

Low-frequency Stimulator (Model: AST-645, AST-646)

Shenzhen Osto Technology Co., Ltd.

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

Surgical Instrument Service and Savings, Inc.

Dragonfly OpStar™ Imaging Catheter

ABBOTT MEDICAL

TruPress

Procerus Enterprises

Plasma IQ

Neauvia North America, Inc.

cmAngio® V2.0

Curemetrix, Inc.

HAnano InterFuse(R) Modular Interbody

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