K-DEFIB/PACE PEDIATRIC ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION OF STERILITY CYCLE PARAMETERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ULTRA SOFTWARE MODULE: MODEL 2016

FDA 510(k)

FDA Class 3 ·Cardiovascular

M2A/C2A ACETABULAR SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 250 DEFIBRILLATOR/MONITOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, ASTRA T4, ASTRA T6

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONICS MODELS 8320/8322/8329

FDA 510(k)

FDA Class 3 ·Cardiovascular

MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 300

FDA 510(k)

FDA Class 3 ·Cardiovascular

ARCOS INTERLOCKING DISTAL STEMS

FDA 510(k)

FDA Class 3 ·Orthopedic

LIFEPAK 12

FDA 510(k)

FDA Class 3 ·Cardiovascular

FAST-PATCH

FDA 510(k)

FDA Class 3 ·Cardiovascular

Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

FDA classification

FDA Class 3 ·Peripheral Electromagnetic Field (Pemf) To Aid Wound Healing

Gases Used Within Eye To Place Pressure On Detached Retina

FDA classification

FDA Class 3 ·Gases Used Within Eye To Place Pressure On Detached Retina

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA classification

FDA Class 3 ·Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification

FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS