510(k) Device Clearances

JetBoots PRO Plus

Therabody, Inc.

Volta AF-Xplorer II

Volta Medical

EvoEndo Single-Use Endoscopy System

EvoEndo, Inc.

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

Abbott Molecular

Dunamis Screw and Suture Locking System

Dunamis Medical, LLC

Masimo O3 Regional Oximeter System

Masimo Corporation

Intrelief

Easymed Instruments Co., Ltd.

uNion® MAX Cervical Plate System

Ulrich Medical USA, Inc.

ASUS Ultrasound Imaging System (LU800 series)

Asustek Computer, Inc.

OTOPLAN

Cascination AG

Ultimate rTMS; Yingchi rTMS

Brain Ultimate, Inc.

esolution

S4 Medical Corp.

Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter

Global Life Sciences Solutions USA, LLC

GORE® PROPATEN® Vascular Graft

W. L. Gore & Associates, Inc.

Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs,

Eco Medi Glove Sdn. Bhd.

PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX

Bard Peripheral Vascular, Inc.

iCOquit® Smokerlyzer®

Bedfont Scientific, Ltd.

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)

Humanwell Healthcare Group Medical Supplies Co., Ltd.

Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled

Innovative Health, LLC

Ellian Enigma RF Device

Ellian Corp

Disposable Surgical Face Mask

Efofex, Inc.

Navigation Module of the Cortium® System

Ulrich Medical USA, Inc.

CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System

Dentsply Sirona

EConsole2

DRTECH Corporation

Vlab

Dormotech Medical, Ltd.

ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP

Depuy Ireland UC

PennPET Explorer Positron Emission Tomograph

Trustees of the University of Pennsylvania

Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Reso

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

CEDIA Heroin Metabolite (6-AM) Assay

Microgenics Corporation

Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate

Stryker Craniomaxillofacial (Cmf)