ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR

FDA 510(k)

FDA Class 1 ·General Hospital

INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG

FDA 510(k)

FDA Class 2 ·Anesthesiology

DAUM BIOPSYGUN

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIASCOPE V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Estesil H2TOP EHF Extra High Flowability Gun Mix 1:1 FAST

Device

EU MDR · Eu Md Class 1 ·TOKUYAMA DENTAL ITALY S.R.L.·On the market·25 countries

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·2490G/H/J CARELINK MONITOR, 2020A CARDIOSIGHT READER

Current Health System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOXAR'S CALCIUM SCORING PRODUCT

FDA 510(k)

FDA Class 2 ·Radiology

Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOXAR VC, MODEL 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOXAR 3D PRODUCT FAMILY

FDA 510(k)

FDA Class 2 ·Radiology

VOXAR 3D ENTERPRISE, MODEL 6.1

FDA 510(k)

FDA Class 2 ·Radiology

VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION

FDA 510(k)

FDA Class 2 ·Radiology

Wearable Device, Wearable Package

FDA 510(k)

FDA Class 2 ·Cardiovascular

Current Health System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLUG 'N VIEW 3D, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Blackford Analysis Registration Product Family

FDA 510(k)

FDA Class 2 ·Radiology

VOXAR 3D ENTERPRISE WITH CARDIAMETRIX

FDA 510(k)

FDA Class 2 ·Radiology

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System