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

FDA 510(k)

FDA Class 2 ·Microbiology

INTROSCOPE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CRANK FRAME RETRACTOR

FDA 510(k)

FDA Class 2 ·Neurology

MTS Tetracycline 0.016 - 256 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

DESS Dental Smart Solutions

FDA 510(k)

FDA Class 2 ·Dental

MTS Omadacycline 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

QNext and DG-PT

FDA 510(k)

FDA Class 2 ·Hematology

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

TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS

FDA 510(k)

FDA Class 2 ·Dental

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

FDA 510(k)

FDA Class 2 ·Dental

ri-former Predictive Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

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