iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EksoNR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Fecobionics Anorectal System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EksoNR

FDA 510(k)

FDA Class 2 ·Physical Medicine

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iLet® Dosing Decision Software

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

iLet Bionic Pancreas

FDA UDI

Beta Bionics, Inc.·00850050080046·iLet Bionic Pancreas (Commercial Starter Kit)

Bionic Navigator™

FDA UDI

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729935087·1.2 Installer

Bionic Navigator ™

FDA UDI

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729972518·2.04 Installer

iLet Bionic Pancreas

FDA UDI

Beta Bionics, Inc.·00850050080022·iLet Bionic Pancreas (Pharmacy Starter Kit)

Bionic Navigator™

FDA UDI

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729991328·2.04 Installer

Bionic Navigator™

FDA UDI

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729991380·1.2 Installer

Bionic Navigator™

FDA UDI

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·08714729935094·3.1 Installer

iLet Bionic Pancreas

FDA UDI

Beta Bionics, Inc.·00850050080039·iLet Bionic Pancreas (Government Starter Kit)

ODM

FDA UDI

BIONIME CORPORATION·00883489002372·1 meter - 00883489002372

GE

FDA UDI

BIONIME CORPORATION·10883489084849·The combination products includes 2 boxes(00883...

GE

FDA UDI

BIONIME CORPORATION·00883489001177·

GE

FDA UDI

BIONIME CORPORATION·00883489001337·