ATTUNE Cemented Tibial Base, Fixed Bearing

FDA 510(k)

FDA Class 2 ·Orthopedic

True Form Reshapable Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

014 Hydrophilic Coated PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Boss Crossing Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DePuy Actis DuoFix Hip Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

FDA 510(k)

FDA Class 2 ·Physical Medicine

PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

BionicGym Powered Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

FDA classification

FDA Class 2 ·Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER

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 ·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

Software For Endoscopy Procedure Metrics

FDA classification

FDA Class 2 ·Software For Endoscopy Procedure Metrics