SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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 AMPLICOR HCV V2.0 AND 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 AND 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 ·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

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/RANGER PTCA CATHETERS

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·BIOSENSE WEBSTER TEMPERATURE CABLES

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ANTI-HCV REAGENT PACK AND CALIBRATOR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETERS

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE DUAL-CHAMBER, DDD, TEMPORARY CARDIAC PACEMAKER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·M-VU ALGORITHM ENGINE

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT

FDA 510(k)

FDA Class 2 ·Neurology

ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

FDA 510(k)

FDA Class 2 ·Radiology