510(k) Device Clearances

Break Wave

Sonomotion, Inc.

Rayvolve LN

AZmed

Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel

Qingdao Hightop Biotech Co., Ltd.

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)

Shenzhen Goodwind Technology Development Co., Ltd.

Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software

Brainlab AG

Edwards eSheath Optima introducer set

Edwards Lifesciences

SMR Reverse Liner

Lima Corporate S.P.A.

T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System

Stryker GmbH

IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)

Shenzhen Semlamp Intelligent Technology Co., Ltd.

Mobility Scooter (N3473)

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S No

Shanghai Draeger Medical Instrument Co., Ltd.

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM

Steris Corparation

Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T,

Tianjin Huahong Technology Co., Ltd.

Single Use Hemoclip

Zhejiang Chuangxiang Medical Technology Co., Ltd.

ADVIA Centaur® NT-proBNPII (PBNPII)

Siemens Healthcare Diagnostics, Inc.

Klassic Knee System - Revision Tibial Baseplate

Total Joint Othopedics, Inc.

Pulse Oximeter

Beijing Choice Electronic Technology Co., Ltd.

iotaSOFT® Insertion System

Iotamotion, Inc.

MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit

Siemens Medical Solutions USA, Inc.

Neonav ECG Tip Location System

Navi Medical Technologies

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Circa Scientific, Inc.

HD60 Series Ultrasound Diagnostic System

Qingdao Hisense Medical Equipment Co., Ltd.

Mendaera Guidance System

Mendaera, Inc.

SABER-XA System

Elevation Spine

Biolinq Shine Autonomous Time-in-Range Microsensor

Biolinq Incorporated

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

Shenzhen Jiantuo Electronics Co., Ltd.

Intense Pulsed Light Treatment System (LK-PT)

Nanjing Bestview Laser S&T Co., Ltd.

SafeOp 3: Neural Informatix Systeem

Alphatec Spine, Inc.

SpineUs™ System

Verdure Imaging

Endocem MTA Premixed Regular

Maruchi