Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENSES

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REALTIME INSULIN PUMP

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve

Creos Xenogain Collagen

FDA UDI

Nibec Co., Ltd.·08809186540834·Creos Xenogain Collagen is a combination of pur...

Creos Xenogain Collagen

FDA UDI

Nibec Co., Ltd.·08809186540803·Creos Xenogain Collagen is a combination of pur...

Creos Xenogain Collagen

FDA UDI

Nibec Co., Ltd.·08809186540841·Creos Xenogain Collagen is a combination of pur...

Creos Xenogain Collagen

FDA UDI

Nibec Co., Ltd.·08809186540797·Creos Xenogain Collagen is a combination of pur...

Creos Xenogain Collagen

FDA UDI

Nibec Co., Ltd.·08809186540810·Creos Xenogain Collagen is a combination of pur...

Creos Xenogain Collagen

FDA UDI

Nibec Co., Ltd.·08809186540827·Creos Xenogain Collagen is a combination of pur...

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·IGM ENZYME IMMUNOASSAY

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY (V619IMUD)

FDA Pre-Market Approval

CONCERTO ICD, CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II DF

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK MONORAIL PTCA CATHETER SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM