Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillators

Test, Anti-Tumor Cell Susceptibility

FDA Pre-Market Approval

FDA Class 3 ·BARTELS CHEMORESPONSE ASSAY

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-COMBO® Therapy Cable

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 15 monitor/defibrillator

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·SVS Deployment Catheter and Loader

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Kerpro Ewa Bielecka Marcin Bielecki spółka komandytowa

Importer

🇵🇱 Poland·1 Manufacturer

OtoSight Middle Ear Scope

FDA UDI

Photonicare, Inc.·00850013784004·The OtoSight Middle Ear Scope is intended for u...

OtoSight Middle Ear Scope with Battery

FDA UDI

Photonicare, Inc.·00850013784127·The OtoSight Middle Ear Scope is intended for u...

SUN-WA TECHNOS (EUROPE) GMBH

Importer

🇩🇪 Germany

ULTRABIO

FDA 510(k)

FDA Class 2 ·Radiology

LYSUS INFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODEL 1920 WASTE GAS SCAVENGER

FDA 510(k)

FDA Class 2 ·Anesthesiology

FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ANTISERUM TO HUMAN APOLIPOPROTEIN A-I

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES

FDA 510(k)

FDA Class 2 ·Radiology