Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HDO

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCAP TEST

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER (ADO)

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMADX KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICDO) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo)

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Piccolo™ Occluder

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER II

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD, SOFTEC HD PS, SOFTEC I AND SOFTEC HDO DEVICES.

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)

FIRST MEDIC MODE 610

FDA 510(k)

FDA Class 3 ·Cardiovascular