510(k) Device Clearances

Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-

Tianjin Huahong Technology Co., Ltd.

Ion 3D

SurGenTec, LLC

OptiMesh Multiplanar Expandable Interbody Fusion System

Spineology, Inc.

Equinoxe® Shoulder System

Exactech, Inc.

Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance

Ambu A/S

PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Med

Pentax of America, Inc.

QIAstat-Dx Respiratory Panel Mini

QIAGEN GmbH

Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143

Shenzhen Yicai Health Technology Co., Ltd.

CareSuperb™ COVID-19 Antigen Home Test

Access Bio, Inc.

Visualase V2 MRI-guided Laser Ablation System (9736422)

Medtronic Navigation

HeartFocus

Deski

Cios Spin

Siemens Medical Solutions USA, Inc.

HeartFocus (V.1.1.1)

Deski

EMBOLD Fibered Detachable Coil System

Boston Scientific Corporation

ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH

Livsmed, Inc.

Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter

Boston Scientific

Disposable Face Mask

Jiujiang Taixin Technology Co., Ltd.

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems

Siemens Medical Solutions USA, Inc.

StageOne™ Select Hip Cement Spacer Molds

Biomet, Inc.

ANTERION

Heidelberg Engineering GmbH

SOZO Pro

ImpediMed Limited

accufit

Mettler Electronics Corporation

Plenity

Gelesis, Inc.

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

Bd

Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

Plasma Concepts

PADLOCK CLIP EFTR Kit (00713229)

STERIS Corporation

syngo.CT Extended Functionality

Siemens Medical Solutions USA, Inc.

ArthroTAK Tendon Anchor Kit

ArthroTAK, LLC

Cranial EM System

Brainlab AG

FIX-C PEEK Anterior Cervical Interbody System

Jeil Medical Corporation