510(k) Device Clearances

Deep Learning Image Reconstruction

Ge Medical Systems, LLC

Tembo Embolic System

Instylla, Inc.

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

Diazyme Laboratories, Inc.

LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (B

Huizhou Foryou Medical Devices Co., Ltd.

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

Beijing Konted Medical Technology Co.,Ltd

Ezra Flash

Ezra Ai, Inc.

LOGIQ P10, LOGIQ P9, LOGIQ P8

GE Medical Systems Ultrasound and Primary Care Diagnostics

Sim&Size

Sim&Cure

Electronic Blood Pressure Monitor

Shenzhen Pango Medical Electronics Co., Ltd.

ClearPoint Bone Screw Fiducials

ClearPoint Neuro, Inc.

uDR 380i Pro

Shanghai United Imaging Healthcare Co., Ltd.

Tornus ES

Asahi Intecc Co., Ltd.

Portable Wheelchair

Intradin (Shanghai) Machinery Co., Ltd.

3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallma

Orthofix US, LLC

Clavicle and Scapula System

Auxein Medical Pvt., Ltd.

SonoTAP and SonoTAP II

PAJUNK GmbH Medizintechnologie

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matr

Berkeley Advanced Biomaterials

eClinic Stethopod

Homediagnostic, LLC

Apex Locator (FindPex)

Changzhou Sifary Medical Technology Co., Ltd.

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

Shenzhen Kentro Medical Electronics Co., Ltd.

Surgical Microscope (OMS2360, OMS2380)

Zumax Medical Co., Ltd.

Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System

Zavation Medical Products, LLC

KEOPS Balance Analyzer 3D

S.M.A.I.O

i-STAT CG8+ cartridge with the i-STAT 1 System

Abbott Point of Care, Inc.

EVA15 insufflator

Palliare , Ltd.

Sempulse Halo Vital Signs Monitor

Sempulse Corporation

Single-use Sterile High-pressure Angiographic Syringes and Accessories

Shenzhen Boon Medical Supply Co., Ltd.

Multifrax Laser System

Paradigm Medical Corporation

Auryon Atherectomy System

Eximo Medical, Ltd.

Alien Aligners

Alien Milling Technologies