Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT

NA

FDA UDI

DOMICO MED-DEVICE, LLC·00810050244381·E6328BG PATIENT TRANSFER BOARD

NA

FDA UDI

DOMICO MED-DEVICE, LLC·00810050244398·E6328BH PATIENT TRANSFER BOARD

NA

FDA UDI

DOMICO MED-DEVICE, LLC·00810050243544·PAD, UNIVERSAL STRETCHER, STANDARD

MMT-7763A Guardian Link Transmitter

FDA registration

MEDTRONIC MINIMED·1 product·🇺🇸 United States

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TRU LEGIONELLA

FDA 510(k)

FDA Class 2 ·Microbiology

ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

JBAIDS PLAGUE DETECTION KIT

FDA 510(k)

FDA Unclassified ·Unknown

LEGIONELLA STAT IGG/IGM TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ANTI-DNASE B REAGENT SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA PNEUMOPHILA IGG/IGM

FDA 510(k)

FDA Class 2 ·Microbiology

BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

TRU Legionella

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX LEGIONELLA URINARY ANTIGEN EIA

FDA 510(k)

FDA Class 2 ·Microbiology

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 22 Cochlear Implant Systems

Helix Genetic Health Risk App for late-onset Alzheimer’s disease

FDA 510(k)

FDA Class 2 ·Immunology

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry