PGDx elio plasma focus Dx

FDA 510(k)

FDA Class 2 ·Pathology

AAMI Level 4 Protective; Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ProTEC-USA EZDoff Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diazo Colorimetry, Bilirubin

FDA classification

FDA Class 2 ·Diazo Colorimetry, Bilirubin

Injectable Root Canal Bioceramic Sealer (i-MTA SP)

FDA 510(k)

FDA Class 2 ·Dental

Medical Diode Laser (Model: L2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Diode Laser (M2-GK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

FDA 510(k)

FDA Class 2 ·Dental

Medical Diode Laser (S1Pro)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Therapy Device (DF-DIODE LASER-S1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

High Flow/High Velocity Humidified Oxygen Delivery Device

FDA classification

FDA Class 2 ·High Flow/High Velocity Humidified Oxygen Delivery Device

Test, Immunoassay, Biosensor, Hcg

FDA classification

FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Internal Hinged Elbow Fixator

FDA classification

FDA Class 2 ·Internal Hinged Elbow Fixator

Ultrafiltration-Controlled Nocturnal Dialysate Delivery System

FDA classification

FDA Class 2 ·Ultrafiltration-Controlled Nocturnal Dialysate Delivery System

Foam Or Gel Chemical Sterilant/High Level Disinfectant

FDA classification

FDA Class 2 ·Foam Or Gel Chemical Sterilant/High Level Disinfectant

High Pressure Liquid Chromatography, Barbiturate

FDA classification

FDA Class 2 ·High Pressure Liquid Chromatography, Barbiturate

High Pressure Liquid Chromatography, Opiates

FDA classification

FDA Class 2 ·High Pressure Liquid Chromatography, Opiates

Hemodialyzer, Re-Use, High Flux

FDA classification

FDA Class 2 ·Hemodialyzer, Re-Use, High Flux