Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER/LEAD END PIN CAP/EPICARDIAL PATCH LEAD/ACCESSORY (UPSIZING SLEEVE) FOR UNIPOLAR

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G Pump

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

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

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE FPSA ASSAY

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·PERFLUORON

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G Pump

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE PSA ASSAY

Mob Cap, PE Mob Cap, Bouffant Cap, Doctor Cap, Peaked Bouffant Cap, Snood Cap, Astronaut Cap, Nylon Hair Nets

Basic UDI-DI

EU MDR · Eu Md Class 1 ·ANHUI GUOHONG INDUSTRIAL AND TRADING CO.,LTD·1 device

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Comby EEG cap with 23 Ag/AgCl electrodes, size37-42

Device

EU MDR · Eu Md Class 1 ·Pamel d.o.o.·On the market

Comby EEG cap with 23 Ag/AgCl electrodes, size32-37

Device

EU MDR · Eu Md Class 1 ·Pamel d.o.o.·On the market

10% Neutral Buffered Formalin 125/60 ML - YELLOW CAPS (x24)

Device

EU IVDR · Eu Ivd Class A ·LAURYPATH·On the market·32 countries

10% Neutral Buffered Formalin 180/80 ML - YELLOW CAPS (x24)

Device

EU IVDR · Eu Ivd Class A ·LAURYPATH·On the market·32 countries

10% Neutral Buffered Formalin 60/30 ML - YELLOW CAPS (x35)

Device

EU IVDR · Eu Ivd Class A ·LAURYPATH·On the market·32 countries

10% Neutral Buffered Formalin 20/10 ML - YELLOW CAPS (x24)

Device

EU IVDR · Eu Ivd Class A ·LAURYPATH·On the market·32 countries