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

OvuSense Fertility Monitor System. M026 OvuCore Vaginal Sensor, M426 OvuFirst Skin Worn Sensor and M032 OvuSense App.

FDA registration

viO HealthTech Limited·1 product·🇬🇧 United Kingdom

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

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Hybrid Cochlear Implant

Implant, Auditory Brainstem

FDA Pre-Market Approval

FDA Class 3 ·Nucleus Auditory Brainstem Implant

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant Systems

'EXMOOR' SHAH & MACKAY NASAL SPLINTS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RICHARDS THERMOPLASTIC DORSAL NASAL SPLINT

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

'EXMOOR' CAWOOD NASAL SPLINTS

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat