510(k) Device Clearances

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

Cepheid®

Implanter incl. Accessories

Guilin Woodpecker Medical Instrument Co., Ltd.

Surgical Face Mask

Taiwan Comfort Champ Manufacturing Co., Ltd.

STIMPOD NMS450 Nerve Stimulator

Xavant Technology (Pty), Ltd.

CONTOUR® NEXT GEN Blood Glucose Monitoring System

Ascensia Diabetes Care U.S., Inc.

MedalOne Total Knee System

Suzhou Microport Orthorecon Co., Ltd.

Biotres

Biotricity

HyperSnap Surgical System (HSS)

Hypervision Surgical

GlucoSure Link Blood Glucose Monitoring System

Apex BioTechnology Corp.

GX Navigation Instrument System

Life Spine, Inc.

Perfit FS Dental Zirconia Fully Sintered Block

Vatech Acucera, Inc.

PP Care Nitrile Examination Gloves

Eg Group Product and Services Co., Ltd.

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignm

Brainlab AG

RemeOs™ Screw LAG Solid

Bioretec, Ltd.

JARVIS Diaphyseal Stem Standard

FH Industrie

F&P 950 Respiratory Humidifier

Fisher & Paykel Healthcare

Branchor Balloon Guide Catheter

Asahi Intecc Co., Ltd.

Neocis Guidance System (NGS) with Yomi Plan v2.0.1

Neocis, Inc.

IDx-DR v2.3

Digital Diagnostics, Inc.

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

Iridex Corporation

Certas Plus Programmable Valves

Integra Lifesciences Production Corporation

TDM Lumbar Interbody Fusion Cage System

Tdm Co., Ltd.

Edge Upper Cervical System

Spinal Simplicity, LLC

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Treace Medical Concepts (TMC) Implant Fixation System

Treace Medical Concepts

Model 9160 VitaloQUB

Vitalograph Ireland, Ltd.

TriMed Wrist Fixation System 3

TriMed, Inc.

Solar Lumbar Interbody Fusion System

Degen Medical

Disposable Medical Face Mask

Makrite Industries, Inc.

LIAISON PLEX Yeast Blood Culture Assay

Luminex Corporation