Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RX VOYAGER CORONARY DILATATION CATHETER

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

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 AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·CLEAREAD DETECT

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

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

FDA Pre-Market Approval

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

High Throughput Dna Sequence Analyzer

FDA classification

FDA Class 2 ·High Throughput Dna Sequence Analyzer

System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA classification

FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Reprocessed Bronchoscope

FDA classification

FDA Class 2 ·Reprocessed Bronchoscope

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

FDA classification

FDA Class 2 ·Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

FDA classification

FDA Class 2 ·Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization

System, Suction, Lipoplasty

FDA classification

FDA Class 2 ·System, Suction, Lipoplasty

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

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

FDA classification

FDA Class 2 ·System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

FDA classification

FDA Class 2 ·Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

Next Generation Sequencing Based Tumor Profiling Test

FDA classification

FDA Class 2 ·Next Generation Sequencing Based Tumor Profiling Test

Stationary Infrared Thermometer

FDA classification

FDA Class 2 ·Stationary Infrared Thermometer

Continuous Measurement Thermometer

FDA classification

FDA Class 2 ·Continuous Measurement Thermometer