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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST V2.0/COBAS AMPLICOR HCV TEST V2.0

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

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

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

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HBV CALIBRATOR KIT

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification

FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

Tongue Suspension System

FDA classification

FDA Class 2 ·Tongue Suspension System

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

FDA classification

FDA Class 2 ·Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Dermal Cooling Pack/Vacuum/Massager

FDA classification

FDA Class 2 ·Dermal Cooling Pack/Vacuum/Massager

Dental Amalgam

FDA classification

FDA Class 2 ·Dental Amalgam

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification

FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Sterilizer Automated Loading System

FDA classification

FDA Class 2 ·Sterilizer Automated Loading System

Electrical Tongue Stimulator To Treat Motor Deficits

FDA classification

FDA Class 2 ·Electrical Tongue Stimulator To Treat Motor Deficits

Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

FDA classification

FDA Class 2 ·Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

FDA classification

FDA Class 2 ·Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Intraoral Cooling Device

FDA classification

FDA Class 2 ·Intraoral Cooling Device

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

FDA classification

FDA Class 2 ·Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Shoulder Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Shoulder Arthroplasty Implantation System