NOVA

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480150866·NOVA 8 TUBING HARNESS

Blood Gas and Chemistry Analyzer

FDA UDI

Edan Instruments, Inc.·06944413801875·

GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TEST

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950807582·GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl...

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480289535·STAT PROFILE pHOx PLUS/L/C AIR DETECTOR

STAT PROFILE

FDA UDI

NOVA BIOMEDICAL CORPORATION·00385480289542·STAT PROFILE pHOx PLUS/L/C REFERENCE SENSOR

GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST

FDA UDI

INSTRUMENTATION LABORATORY COMPANY·08426950807681·GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl...

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS EON,EONC,EON MINI,PROTEGE,PROTEGE MRI,AND PROCLAIM FAMILY SPINAL CORD STIMULATION (SCS) SYSTEMS

10.72XXLTRN_BARIATRICO - LETTO ELETTRICO XXL CON TESTATE NURSING CON RUOTE

Device

EU MDR · Eu Md Class 1 ·VASSILLI S.R.L.·On the market

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON AND GENESIS RC NEUROSTIMULATION SYSTEMS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EonC and Eon Mini Neurostimulation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ANS EON C (IPG) NEUROSTIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS RC AND EON NEUROSTIMULATION SYSTEMS

Analyzer

FDA registration

Diamond Diagnostics Inc.·9 products·🇭🇺 Hungary

H ISE REFERENCE ELECTRODE

FDA registration

ROCHE DIAGNOSTICS GMBH·9 products·🇩🇪 Germany

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

VIVACE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry