Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OIL 5000 SILICONE OIL

SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL

FDA 510(k)

FDA Class 3 ·Cardiovascular

MOBILE BATTERY SERVICE STATION (MBSS)

FDA 510(k)

FDA Class 3 ·Cardiovascular

Skintact, various other tradenames

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21

FDA 510(k)

FDA Class 3 ·Cardiovascular

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL SYRINGE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NexGen LPS-Flex/LPS-Mobile Bearing Knee

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS 01 & PIKOS E 01

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

BIOTRONIK'S PS-ENDOCARDIAL LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

FDA 510(k)

FDA Class 3 ·Cardiovascular

TRIOS 02

FDA 510(k)

FDA Class 3 ·Cardiovascular

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP

FDA 510(k)

FDA Class 3 ·Cardiovascular