510(k) Device Clearances

Regeneten Bioinductive Implant

Smith and Nephew, Inc.

Digital ClarusScope System, Digital NeuroPEN System

Clarus Medical, LLC

Hope&Her Vaginal Dilators

Lujena, Inc.

Tamper Evident Cap

International Medical Industries, Inc.

uNion® MAX Cervical Plate System

Ulrich Medical USA, Inc.

KLS Martin Pure Pectus System

KLS Martin L.P.

LOGIQ e

Ge Medical Systems Ultrasound and Primary Care Diagnostic,

Dentca Base Premium, Dentca Base Hi-Impact

Dentca, Inc.

HybridTherm System

Erbe Elektromedizin GmbH

Target Detachable Coils

Stryker Neurovscular

PrevisEA Device

Entac Medical, Inc.

SkinPen Precision System

Crown Aesthetics

Konig Mogen Clamp

Medline Industries, Inc.

Overjet Caries Assist

Overjet, Inc.

VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S7

Olympus Medical Systems Corp.

STERRAD 100NX Sterilizer with ALLClear Technology

Advanced Sterilization Products, Inc.

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Abla

ABBOTT MEDICAL

Mobility Scooter (S-01); Mobility Scooter (S-02)

Zhejiang Seedream Medical Equipment Co., Ltd.

InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

Davol, Inc.

Maestro System (REF100)

Moon Surgical

vWF Ag

Siemens Healthcare Diagnostics Products GmbH

ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLI

Edwards Lifesciences

CogNet QmTRIAGE

Medcognetics, Inc.

Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)

Xiamen Probtain Medical Techology Co., Ltd.

Electric Scooter (Mojo-T580)

Dongguan Smarfody Mobility Technology Co., Ltd.

ArtUs

Telemed

Lyme-ID IgG Test; Bio-ID800

Inanovate, Inc.

AV Vascular

Philips Medical Systems Nederland B.V.