Endo Ultrasonic Activator

FDA 510(k)

FDA Class 2 ·Dental

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Remover, Model: G993, G996, G998 and G885

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOST-T Autoclave

FDA 510(k)

FDA Class 2 ·General Hospital

Combined High Frequency X-ray Source

FDA 510(k)

FDA Class 2 ·Radiology

IPL Hair Remover, Model: G993, G996, G998 and G885

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Curing Light

FDA 510(k)

FDA Class 2 ·Dental

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

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/BOBAS TAQMAN HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV RNA QUALITATIVE ASSAY

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

FDA Pre-Market Approval

FDA Class 2 ·Cobas HCV

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

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan CMV Test

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AmpliPrep/COBAS TaqMan HCV Test

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·cobas CMV

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK, MAVERICK2, MAVERICK XL, QUANTUM MAVERICK

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

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Cobas CMV

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Navistar RMT Electrophysiology Catheter