Jade 37% Phosphoric Acid Etchant Gel

FDA 510(k)

FDA Class 2 ·Dental

Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

FDA 510(k)

FDA Class 2 ·Radiology

ControlRad Sterile Cover

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Vyvo

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND

FDA 510(k)

FDA Class 2 ·Ophthalmic

Acumed Small Bone IM Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

WIRION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUMED PELVIC BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

160841CE01

Certificate

MDD Annex II (excluding section 4)·NP Medical, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

CEFOTAXIME 30 MCG. SENSI-DISC.

FDA 510(k)

FDA Class 2 ·Microbiology

PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry