510(k) Device Clearances

Enteral Syringe (20ml, 60ml)

Chirana T.Injecta,A.S.

cobas pulse blood glucose monitoring system

Roche Diagnostics

REMEX-T(K)100C

Remedi, Inc.

Nanox.ARC

Nano-X Imaging , Ltd.

Arthrex Cannulated Screw System

Arthrex, Inc.

AllureTM Surgical Mask

Allure Gift Wraps Private Limited

Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobr

Hangzhou Tappa Medical Technology Co., Ltd.

Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)

Shenzhen Dongjilian Medical Tech Co., Ltd.

Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set

Xeridiem Medical Devices, A Spectrum Plastics Group Company

DuraGraft Vascular Conduit Solution

Marizyme

Midas Flowmeter; eAVS

Parker Hannifin Corporation

Monotime and Optime R

Peters Surgical

Estar-ZE

Osstem Implant Co., Ltd.

Access anti-HBc Total

Beckman Coulter, Inc.

Syringe with permanently attached needle

Berpu Medical Technology Co., Ltd.

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)

Innovasis, Inc.

Camber Spine Navigation System

Camber Spine Technologies

Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

Feeltech Co., Ltd.

RENASYS EDGE (66803126)

Smith & Nephew Medical, Ltd.

iLet® ACE Pump

Beta Bionics, Inc.

X°Port Lung Preservation System; X°Port Lung Preservation Solution

Traferox Technologies, Inc.

Blood Collection Needle (with/without Needle Holder)

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

Fotona D.O.O.

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1

Integra Lifesciences Production Corporation

Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)

Oriental Inspiration Limited

Voluson P6, Voluson P8

GE Healthcare

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Dig

Zhejiang Geyi Medical Instrument Co., Ltd.

Single-use Extraction Baskets

Scivita Medical Technology Co., Ltd.

HYBRID S70

Digimed Co., Ltd.

Cervical Plating System

Life Spine, Inc.