510(k) Device Clearances

ES1 System

E-Scopics

BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

B.T.I. Biotechnology Institute, Sl.

JETT PLASMA Medical II

Compex, Spol, S.R.O.

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

Roche Molecular Systems, Inc.

Heager Medical Laser Family (Sabrina/Adolf)

Heager GmbH

Quicktome Software Suite

Omniscient Neurotechnology Pty Ltd (O8t)

EchoConfidence (USA)

Mycardium AI Limited

Vascular Assist Occlusion Triage (VAOT) (v1.0)

GuideAI Health

BONREE Nelaton Catheter

Bonree Medical Co., Ltd.

Portable Dental X-ray System Model PDX nova

PDX Co., Ltd.

MedicloseTM System

Health Value Creation B.V., Trading AS Corporis Medical

Nicolet EDX

Natus Neurology Incorporated

ID NOW COVID-19 2.0

Abbott Diagnostics Scarborough, Inc.

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

Medtronic Sofamor Danek USA, Inc.

HOPKINS Telescopes

Karl Storz Endoscopy America, Inc.

Bone Chamber Implant

Megagen Implant Co., Ltd.

VS Tabletop Tonometer

Medimaging Integrated Solution, Inc.

Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)

Microlife Intellectual Property GmbH

InterOss Collagen

Sigmagraft, Inc.

Dentemp Pro-Comfort Dental Guard

Doc Brands, Inc.

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

Xenta Biomedical Science Co., Ltd.

LaserME

Neauvia North America

CRYOcheck Factor VIII Deficient Plasma with VWF

Precision Biologic, Inc.

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System

Alphatec Spine, Inc.

HyperFlex® Bunion Correction System

Hyperflex Medical

Spinal System

Teslake, Inc.

Tyber Medical Anatomical Plating System

Tyber Medical, LLC

Venowave VW5

Thermabright

EndoSign® Cell collection device (ES-CYT-102)

Cyted Limited

Nitrile Patient Examination Gloves

Zhangjiagang Huayuan Protective Equipment Co., Ltd.