510(k) Device Clearances

Nano-Check Influenza A+B Test

Nano-Ditech Corporation

RT Carbon ECG Leads

Ivy Biomedical Systems, Inc.

AspenMed+

Aspen Glove Sdn. Bhd.

Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852)

Jiangxi AOV Maternity & Baby Products Co., Ltd.

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

Shenzhen Aozemei Technology Co., Ltd.

CEREGLIDE 92 Intermediate Catheter

Cerenovus, Inc.

TRI-matrix® X-Force Implants

Tri Dental Implants Int. AG

eRapid Nebulizer System

Pari Respiratory Equipment, Inc.

UNITY VCS (8065000296); UNITY CS (8065000297)

Alcon Laboratories, Inc.

stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; st

Fresenius Medical Care Renal Therapies Group, LLC

DRX-Revolution Mobile X-ray System

Carestream Health, Inc.

Surgical Mask

Sichuan Prius Biotechnology Co., Ltd.

IPL Hair Remover, Model: G993, G996, G998 and G885

Shenzhen Mywin Technology Co., Ltd.

ARIETTA 50

Fujifilm Healthcare Corporation

Ai Ray Dental X-Ray Device

Guilin Woodpecker Medical Instrument Co., Ltd.

FOX 810, FOX 980

A.R.C Laser GmbH

TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System

Sinocare, Inc.

Dukal Crepe Paper Sterilization Wrap

Dukal, LLC

Unscented Tampon

Shandong Intco Hygiene Products Co., Ltd.

Medical PVC Examination Gloves

Jiangxi Hongda Medical Equipment Group , Ltd.

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

Roche Molecular Systems, Inc.

ATTIVA

Italian Engineering S.R.L.

RayStation 11.0

RaySearch Laboratories AB (PUBL)

PROMO

DRGEM Corporation

SpotLight/SpotLight Duo (with DLIR option)

Arineta , Ltd.

EXPD 4343D; EXPD 3643D

DRTECH Corporation

Dental CT Scanner AXR

Alliage S/A Industrias Medico Odontológica

Macro & Micro-Test HCG Pregnancy Test Midstream

Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Fixone Biocomposite Anchor

Aju Pharm Co., Ltd.

PS System

Inter-Med, Inc.