Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV Immunoassay

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RX VOYAGER CORONARY DILATATION CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

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

Sacroiliac Joint Guidewire Placement Device

FDA classification

FDA Class 2 ·Sacroiliac Joint Guidewire Placement Device

Spacer, Direct Patient Interface

FDA classification

FDA Class 2 ·Spacer, Direct Patient Interface

Ophthalmic Syringe

FDA classification

FDA Class 2 ·Ophthalmic Syringe

Esophageal Sheath With Distal Balloon Anchor

FDA classification

FDA Class 2 ·Esophageal Sheath With Distal Balloon Anchor

Intervertebral Body Graft Containment Device

FDA classification

FDA Class 2 ·Intervertebral Body Graft Containment Device

Resuscitator, Manual, Non Self-Inflating

FDA classification

FDA Class 2 ·Resuscitator, Manual, Non Self-Inflating

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

FDA classification

FDA Class 2 ·Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

FDA classification

FDA Class 2 ·Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained