Cognition Chronicle

FDA UDI

Qr8 Health Inc·00860007318733·

Cognition Snapshot v2.0

FDA UDI

Qr8 Health Inc·00860007318719·

Cognition Snapshot+ 2.3.0

FDA UDI

Qr8 Health Inc·00860007318771·

ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NON APPLICATOR TAMPON, UNTREATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TAMPON, UNTREATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NOVA(TM) PULSE GENERATOR 7 RX 2000(TM) PROGRAMMER

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

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

BabySat 3 Rx Base Station

FDA UDI

Owlet Baby Care Inc.·00810099090024·

Nurture Rest

FDA 510(k)

FDA Class 1 ·General Hospital

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon catheter

FDA Pre-Market Approval

CALCIVIS Imaging System

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon Catheter

FDA Pre-Market Approval

CALCIVIS Imaging System

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·4Kscore Test