Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera (TM) System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Aortic Stent

FDA Pre-Market Approval

FDA Class 3 ·Minima Stent System

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6726 DF-1-Y-ADAPTOR/EXTENDER KIT

PD-L1 IHC 28-8 pharmDx

FDA UDI

AGILENT TECHNOLOGIES, INC.·05700571108161·PD-L1 IHC 28-8 pharmDx

PD-L1

FDA UDI

BIOCARE MEDICAL LLC·00847627004567·

PD-L1 IHC 22C3 pharmDx

FDA UDI

AGILENT TECHNOLOGIES, INC.·05700573003563·PD-L1 IHC 22C3 pharmDx

PD-L1 IHC 22C3 pharmDx

FDA UDI

AGILENT TECHNOLOGIES, INC.·05700571107300·PD-L1 IHC 22C3 pharmDx

CDF-20

Basic UDI-DI

EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

CDF-10

Basic UDI-DI

EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

CDF-25

Basic UDI-DI

EU MDR · Eu Md Class 1 ·MOBERCAS SL·1 device

ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

ONE STEP Malaria P.F/Pan Tri-line Rapid Test (Colloidal Gold)

Device

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

CHLAMYDIA TRACHOMATIS ANTIGEN TEST

FDA 510(k)

FDA Class 1 ·Microbiology

WECK CONCENTRATED LIQUID CLEANER

FDA 510(k)

FDA Class 1 ·General Hospital

WECK INSTRUMENT CLEANER, CAT. NO. 850-103

FDA 510(k)

FDA Class 1 ·General Hospital

WECK-LUBE, CATALOG NO. 850-150

FDA 510(k)