Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Legacy MDT Pocket Adapter

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, MDR CORP.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD, EMBLEM MRI S-ICD,

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICON UV-ABSORBING POSTERIOR CHAMBER IOL

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·COSEAL SURGICAL SEALANT & ACCESSORIES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD, SPLITTER/ADAPTOR, DF-4 IMPLANT TOOL KIT FOR MDT LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE IS-1 LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADET V-105 C AND D AND V-115 C AND D PULSE GENERATORS & SOFTWARE VERSION 4.1 FOR THE PROGRAMMER MDL PR-1500

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

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

KALOS 05 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

DNP 60-B UNIPOLAR ENDOCARDIAL LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM