Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Levofloxacin 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Imipenem 0.016-256 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Tetracycline 0.016 - 256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Omadacycline 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Filbloc

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intensity Pulsed Light Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)

FDA 510(k)

FDA Class 2 ·Physical Medicine

SMR Reverse HP Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

MTS Ceftobiprole 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PERMATINT(R)