Heaxel

FDA UDI

HEALTH PIXEL SRL·08054329990001·Robotic system for neurorehabilitation and reha...

InMotion ARM

FDA UDI

BIONIK, INC.·00860001346701·

InMotion ARM/HAND

FDA UDI

BIONIK, INC.·00860001346718·

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF

FDA UDI

JK-Products GmbH·EJKP100003355A0·

Stryker Fecal Management System

FDA UDI

SAGE PRODUCTS, LLC·00618029980274·Stryker Fecal Management System

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape

FDA UDI

JK-Products GmbH·EJKP100003334A0·

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF

FDA UDI

JK-Products GmbH·EJKP100003356A0·

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape

FDA UDI

JK-Products GmbH·EJKP100003333A0·

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM

silicone nub strap 158 (L)

Basic UDI-DI

EU MDD · Eu Md Class 1 ·3mach GmbH·1 device

M.I.Tech Co., Ltd

Manufacturer

🇰🇷 South Korea·809 Basic UDI-DIs·809 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM, WAVE COMMUNICATOR MODEL 6290; NXT SYSTEM SEVER SOFTWARE MODEL 6460

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Endoscopic Ablation System

AAV5 NAb Test Specimen Collection Kit

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Precision for Medicine, Inc.·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Unify™, Unify Quadra™, Unify Assura™, Quadra Assura™, Quadra Assura MP™, Avant, Neutrino NxT, Gallant, Entrant

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC-43,44,45 NB UV ABSORBING IOL