Mark 5 Nuvo Lite

Device

EU MDD · Eu Md Class 2a ·Nidek Medical Products Inc.·On the market·13 countries

LiMAx breathing mask

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Humedics GmbH·1 device

LiMAx device

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Humedics GmbH·1 device

LIA-Liver-Profile

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·1 device

EyeGiene Insta-Warmth Mask System

FDA registration

EYEDETEC MEDICAL, INC.·1 product·🇺🇸 United States

TYPE 9293 INTERFACE PULSEOX

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARRHYTHMIA 9215

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUCORE TELEMETRY, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFE-1

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9290 INTERFACE RESPIRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

NIBP 9225 COMBI

FDA 510(k)

FDA Class 2 ·Cardiovascular

TCPO2 9260 MODULE - SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Anesthesiology

TYPE 9210 ECG SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE INTERFACE 9271/1 INCUBATOR/WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

SYSTEM ATHENA, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9220 PRESS 1 & 2 SYSTEM ATHENA

FDA 510(k)

FDA Class 2 ·Cardiovascular

TYPE 9140/NEO

FDA 510(k)

FDA Class 2 ·Cardiovascular