1,614 results · 39ms · Sources: EU EUDAMED, US FDA

Fluid, Hysteroscopy

FDA Pre-Market Approval
FDA Class 3 ·HYSKON (32% DEXTRAN 70)

ELECTRO-CAP W/POZ-LARGE/MEDIUM

FDA UDI
ELECTRO-CAP INTERNATIONAL INC·00811478011227·

ELECTRO-CAP W/POZ-MEDIUM/SMALL

FDA UDI
ELECTRO-CAP INTERNATIONAL INC·00811478011241·

ELECTRO-CAP W/POZ-SMALL/EXSM

FDA UDI
ELECTRO-CAP INTERNATIONAL INC·00811478011265·

Medical Diode Laser Hair Removal Device

Device
EU MDD · Eu Md Class 2b ·Zhengzhou PZ Laser Slim Technology Co., Ltd.·On the market·3 countries

TK PZA KIT

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Innovative Biotechnology Organization Trade Limited Company·1 device

PLASTIC SUNGLASSES

FDA 510(k)
FDA Class 1 ·Ophthalmic

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SPZ/Z NOVUS/SP NOVUS LEADS/VITATRON EXCELLENCE S+/SS+/VITATRON IMPULSE/IMPULSE II

Models 3543A, 4343A, 2929A and A843B

FDA 510(k)
FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·UNPRESERVED CONSEPT-2 RINSING & NEUTRALIZING SOL.

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE SP,Z,Z NOVUS,SP NOVUS

NA

FDA UDI
Hangwei GE Medical Systems Co., Ltd.·00840682141932·

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Ophthalmic Sealant

FDA Pre-Market Approval
FDA Class 3 ·RESURE SEALANT

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre 14-day Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre 14 Day Flash Glucose Monitoring System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System