DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC

FDA 510(k)

FDA Class 2 ·Ophthalmic

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Tyece OTC TENS Device

FDA 510(k)

FDA Class 2 ·Neurology

Tyece OTC EMS System

FDA 510(k)

FDA Class 2 ·Physical Medicine

SHOWER STRETCHER W/WHEELS

FDA 510(k)

FDA Class 2 ·General Hospital

Tyece OTC TENS Model

FDA 510(k)

FDA Class 2 ·Neurology

Tyece OTC EMS System, Model EM35

FDA 510(k)

FDA Class 2 ·Physical Medicine

IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICRO-INGRESSOR HANDIPIECE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FIAX HAPTOGLOBIN TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

ANAZYME ANA PEROXIDASE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

HAPTOGLOBIN IMMUNOLOGICAL TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN

FDA 510(k)

FDA Class 2 ·Immunology

IP SPECIFIC G

FDA 510(k)

FDA Class 2 ·Immunology