SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SHIGELLA BOYDII GROUP C2 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SERO-STAT STREPTOCOCCUS TEST

FDA 510(k)

FDA Class 1 ·Microbiology

MYCOPLASMA PNEUMONIAE CF ANTIGEN

FDA 510(k)

FDA Class 1 ·Microbiology

SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

STREP-TEX

FDA 510(k)

FDA Class 1 ·Microbiology

SAS SALMONELLA O POLY B ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

STREPTO-SEC TM

FDA 510(k)

FDA Class 1 ·Microbiology

IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST

FDA 510(k)

FDA Class 1 ·Microbiology

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect system

Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BD Veritor™ Plus CLIA-Waived Combo Pack

FDA UDI

BECTON, DICKINSON AND COMPANY·00382902560746·Combo Veritor Plus CLIA- Waived Flu Kit

BD Veritor™ System Laboratory Combo Pack

FDA UDI

BECTON, DICKINSON AND COMPANY·00382902560739·BD Veritor™ System Laboratory Combo Pack Contai...

BD Veritor™ Plus Laboratory Combo Pack

FDA UDI

BECTON, DICKINSON AND COMPANY·00382902560708·Combo Veritor Reader 2 Hospital Flu Kit

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra App and Azure Astra DR/SR/XT MRI SureScan IPGs

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment