TandemHeart Pump and Escort Controller

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitalFlowTM Centrifugal Pump

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitalFlow Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CentriMag™ Acute Circulatory Support System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LifeSPARC System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitalFlow™ Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

LifeSPARC System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

FDA classification

FDA Class 2 ·Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

FDA 510(k)

FDA Class 2 ·Dental

ARTHREX TENODESIS FAMILY

FDA 510(k)

FDA Class 2 ·Orthopedic

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

QFR (3.0)

FDA 510(k)

FDA Class 2 ·Radiology

MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR

FDA 510(k)

FDA Class 2 ·Radiology

NewTom VGi evo

FDA 510(k)

FDA Class 2 ·Radiology

NewTom 5G

FDA 510(k)

FDA Class 2 ·Radiology

NEWTOM VGI AND NEWTOM 5G

FDA 510(k)

FDA Class 2 ·Radiology

NEWTOM 5G / NEWTOM 5G VERSION FP

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FULL FIELD DIGITAL MAMMOGRAPHY

BIOJET

FDA 510(k)

FDA Class 2 ·Radiology