510(k) Device Clearances

KALA Therapy Wand (Model: KALA-03)

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Lexa MINI (RIS-303, RIS-305)

W&H Sterilization S.R.L.

Dental Desensitizer

Guangzhou Beogene Biotech Co., Ltd.

Auryon Atherectomy System

Eximo Medical

FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

Assure Tech. (Hangzhou) Co, Ltd.

Elecsys Phospho-Tau (217P) Plasma

Roche Diagnostics

Medical Disposable Sterile Needle Electrode

Suzhou Haishen Medical Device Associates Co., Ltd.

Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedi

Stryker Leibinger GmbH & Co KG

EFAI ChestSuite XR Pneumothorax Assessment System

Ever Fortune.Ai, Co., Ltd.

FAICO Dental Implant System and CAD/CAM Abutments

Faico Medical, LLC

Shield System (Siemens 30x40)

Radiaction , Ltd.

X-Pac Expandable Lumbar Cage System

Expanding Innovations, Inc.

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introdu

Clinical Laserthermia Systems, AB

OPN NC PTCA Dilatation Catheter

Sis Medical AG

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

Rayence Co., Ltd.

TauTona Pneumoperitoneum Assist Device (TPAD)

Tautona Group Research & Development, Co., LLC

Mosaic (V1.0.1)

Navier Medical

CoreLink Navigation Instruments

Corelink, LLC

Transit-Pellets

Medifactia AB

Turbo-Elite Laser Atherectomy Catheter

Spectranetics

Straumann® PURE Ceramic Implants

Institut Straumann AG

Pulse Oximeter

Beijing Choice Electronic Technology Co., Ltd.

ONLINE DAT Benzodiazepines II

Roche Diagnostics

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical

Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

Merit Medical Pte. , Ltd.

Vent Creativity Knee v1.0 (Hermes)

Vent Creativity

Ultrast Gel

Ultrast, Inc.

Medical Monitor (40HT513D)

Lg Electronics.Inc

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

Atmos Medizintechnik GmbH & Co. KG

SR-1 Skin Treatment System

AVAVA, Inc.